MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	MT22719
Medical Device Problem Codes	Imprecision (1307); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.Reportedly, the patient used more than one bg meter during their sensor session.The sensor was inserted at the leg on (b)(6) 2018.No additional event or patient information is available.The device has been received for evaluation.  a follow-up report will be submitted once the evaluation is complete.Labeling indicates: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.Labeling indicates: always use the same meter you routinely use to measure your blood glucose.Blood glucose meter and strip accuracy vary between meter brands.Switching within a session might cause sensor glucose readings to be less accurate.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was received for evaluation and passed external visual inspection.The receiver successfully booted and charged.The receiver download log was reviewed and there were no issues related to the customer complaint.All estimated cgm values shown on the receiver are within the accurate value range.The device passed global receiver functional testing.The reported allegation was not found and the customer complaint was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 7246558
• Report Number: 3004753838-2018-12983
• Device Sequence Number: 1044477
• Product Code: PQF
• UDI-Device Identifier: 00386270000606
• UDI-Public: 00386270000606
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STK-MC-001
• Device Lot Number: 5227005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR