MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9500-27 STS-GL-011 manufactured by Dexcom, Inc..
[93889288]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93889289]
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. No additional event or patient information is available. No data was provided for evaluation. Confirmation of the problem and probable cause could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2017-107060 |
| MDR Report Key | 7079104 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-12-04 |
| 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 | 0 |
| Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | PJT |
| Date Received | 2017-12-04 |
| 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 DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-04 |