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Class 1 Device Recall Dexcom G4 PLATINUM (Professional)


Class 1 Device Recall Dexcom G4 PLATINUM (Professional)

Product: Dexcom G4 PLATINUM (Professional) Receiver
Receiver Part Number: MT20649 Receiver (mg/dL), Black.
                                      Intended to detect trends and track glucose patterns in persons with diabetes.
                                      The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ
                                       due to other kit contents, such as indications for use and professional receiver shield.
 
Code Information Receiver Kit Number:
STK-PU-001

Lot Number:
5176532
5176533
5176534
5176535
5176536
5188586
5189596
5190560
5191152
5191737
5191738
5192934
5193038
5194193
5194322
5195147
5195148
5195352
5195803
5195913
5196152
5197013
5197677
5198614
5200903
5200904
5200916
5201455
5201669
5202100
5202149
5202429
5202646
5202790
5202795
5202803
5202804
5202906
5203313
5203474
5203485
5203536
5204330
5204333
5205041
5206612
5206643
5208018
5208332
5208810
5210472

Recalling Firm/Manufacturer:  Dexcom Inc
                                                 6340 Sequence Dr
                                                 San Diego CA 92121-4356

For Additional Information Contact:
Dedicated Hotline 844-607-8398

Manufacturer 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: 
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 periodically 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.

Contact:

Dexcom Inc: Dedicated Hotline 844-607-8398