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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-2
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The receiver has been received for evaluation. A follow-up report will be submitted once the evaluation is complete.
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver initialized without a manual restart. No additional event or patient information is available. The product was received for evaluation. A follow-up report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. An external visual inspection was performed and passed. The receiver failed to charge and boot up due to device will not power on. Functional test cannot be performed due to power issues. The receiver log could not be downloaded due to power issues. The receiver case was opened and the internal inspection reveals dead battery of 0v. The download log with replacement battery passed due to log shows no signs of perpetual rebooting or initializing. The allegation was not confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego, ca CA 92121
MDR Report Key7975779
MDR Text Key124683829
Report Number3004753838-2018-125122
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-109
Device Lot Number5233546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No

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