MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-27 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR 9500-27 STS-GL-011 manufactured by Dexcom, Inc..
[78598243]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78598244]
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted into the arm on (b)(6) 2017. No additional event or patient information is available. Data was provided for evaluation. Data review confirmed the reported event of inaccurate cgm values. A root cause could not be determined via data. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2017-55210 |
| MDR Report Key | 6672386 |
| Report Source | CONSUMER |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KIPP DURBIN |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582000200 |
| Manufacturer G1 | DEXCOM, INC. |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQF |
| Date Received | 2017-06-27 |
| Model Number | 9500-27 |
| Catalog Number | STS-GL-011 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PFQ |
| Date Received | 2017-06-27 |
| Model Number | 9500-27 |
| Catalog Number | STS-GL-011 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |