Recall Z-1335-2016
Dexcom Inc · initiated February 23, 2016
Class I – dangerous or defective products that could cause serious health problems or death
Product
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
Codes / lots: Receiver Kit Number: STK-KD-001 STK-KX-001 STR-KD-001 STK-KD-PNK STK-KX-PNK STR-KD-PNK STK-KD-BLU STK-KX-BLU STR-KD-BLU Lot Number: 5120310 5135364 5135371 5136498 5150416 5150452 5159486 5166429 5166430 5178449 5179449 5187476 5189594 5190724 5191132 5191133 5191174 5191809 5191810 5191849 5192890 5194119 5194120 5194121 5194431 5195411 5195746 5195763 5195776 5195784 5196133 5196159 5197032 5197033 5197647 5120312 5135362 5135368 5135380 5136502 5139380 5150418 5150454 5153433 5159487 5166433 5166449 5166450 5171430 5178418 5178456 5179453 5187474 5189590 5190725 5191105 5191134 5191135 5191408 5191839 5191840 5191841 5192942 5193958 5193959 5193960 5194123 5194432 5194433 5195412 5195459 5195747 5195766 5195965 5195969 5195972 5196087 5196134 5196918 5197034 5197035 5197614 5197615 5120311 5135363 5135366 5135381 5136500 5139379 5150417 5150453 5159488 5166434 5166435 5171431 5178451 5179451 5187426 5187475 5188748 5191106 5191136 5191409 5191836 5191837 5193810 5194186 5194335 5194400 5194563 5195413 5195745 5195768 5195785 5195973 5197036 5197037 5197038 5197608 5126237 5135369 5136504 5142406 5142408 5142415 5167425 5179455 5189600 5194188 5194562 5195759 5195786 5196151…
Reason for recall
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
FDA-determined cause: Device Design
Action taken
Dexcom sent out a customer notification letter by certified mail to all direct customers on 02/23/16 notifying customers that they may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. As a result customers may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event. The letter instructs the customer to peridically test the alarms and alerts on their receiver to make sure that the alarms and alerts are functioning properly (especially if the receiver gets wet of is dropped). Receiver part numbers and instructions for testing the alarms and alerts can be found on the back of the notification as well as in the User's Guide. Should customers find that alarms and alerts are not functioning properly or if any questions regarding the notification contact the deciated hotline tool free at 844-607-8398 or dial 858-291-1700. The healthcare professional notification that was sent out provided similar instructions as the direct customer notificaiton in which it is recommended that healthcare professionals periodically check the speaker function by following the testing instructions attached in the notification. The distributor notification letter instructed them to take the following actions: Hold shipments of Dexcom receivers and sticker all existing Dexcom receiver boxes on the outside front of the box with the enclosed notification stickers (see the attached visual guide for sticker placement). Once completed can begin shipping the products. In order to ensure that the notification is timely received by patients select one of the following two (2) options by no later than February 25, 2016: Send, via certified mail, the notification directly to those patients that have purchased a Dexcom receiver from you. If elect this option, Dexcom will provide the required quantity of notifications enclosed in certified mail envelopes. In order to facilitate this effort email the number of notifi
Details
- Recall number
- Z-1335-2016
- Initiated
- February 23, 2016
- Posted by FDA
- April 11, 2016
- Terminated
- August 11, 2017
- Product code
- MDS – Sensor, Glucose, Invasive
- Quantity
- 18,004
- Distribution
- Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
- Recalling firm
- Dexcom Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1334-2016 Class I | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1336-2016 Class I | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1337-2016 Class I | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL)…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1338-2016 Class I | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1339-2016 Class I | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |