MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-01 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-GF-001 manufactured by Dexcom, Inc..
[115789731]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[115789732]
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a pairing failure between the transmitter, receiver, and smart device occurred. No additional patient or event information is available. No product was provided for evaluation. Data was provided for evaluation. Data review did not confirm the reported event of pairing failure. A root cause could not be determined via data. The reported issue of pairing failure is reportable based on the finding of transmitter failure error.
Patient Sequence No: 1, Text Type: D, B5
[139207993]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139207994]
Product was returned. An exterior physical visual inspection was performed and passed. A voltage measurement was taken and failed at 0 vdc. A share log review was performed and a failure to pair was found. A fatal error was observed for a different tx id (b)(4) and is not related to this investigation. The alleged transmitter has already been scrapped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2018-078472 |
| MDR Report Key | 7741637 |
| Report Source | CONSUMER |
| Date Received | 2018-08-01 |
| Date of Report | 2019-03-04 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2017-08-04 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | MR KIPP DURBIN |
| Manufacturer Street | 6340 SEQUENCE DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582000200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PQF |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-25 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 6004138 |
| Device Expiration Date | 2018-03-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | PQF |
| Product Code | PFQ |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-25 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 6004138 |
| Device Expiration Date | 2018-03-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |