Recall Z-1338-2016 ยท MDS Sensor, Glucose, Invasive
Dexcom Inc
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
| Date | Apr 11, 2016 (initiated Feb 23, 2016) |
| Status | Terminated |
| Reason | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Root cause | Device Design |
| Action | 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 testin |
| Quantity | 19,586 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.