MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-04 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-GF-001 manufactured by Dexcom, Inc..
[132427668]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132427669]
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, patient reported a pairing failure. The transmitter has been received for evaluation. An external visual inspection was performed and the transmitter passed. A voltage test was performed and the transmitter failed as it has 0 voltage. The share log was reviewed and did not show a pairing failure but a transmitter failure error was observed. The customer complaint of a pairing failure was not confirmed. The root cause could not be determined. The reported issue of a pairing failure is reportable based on the finding of a transmitter failure error. No additional patient or event information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2019-002247 |
| MDR Report Key | 8219787 |
| Report Source | CONSUMER |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2018-08-27 |
| Date Added to Maude | 2019-01-04 |
| 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 | 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 | 2019-01-04 |
| Returned To Mfg | 2018-12-03 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 7242424 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PFQ |
| Date Received | 2019-01-04 |
| Returned To Mfg | 2018-12-03 |
| Model Number | 9438-06 |
| Catalog Number | STT-GF-001 |
| Lot Number | 7242424 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-04 |