MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-27 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9500-27 STS-MC-001 manufactured by Dexcom, Inc..
[140037264]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140037265]
Dexcom was made aware on 02/28/2019, that on (b)(6) 2018, a detached sensor wire was reported. The sensor was inserted into the abdomen. The patient stated the sensor wire detached from the sensor and remained under her skin on her lower left abdomen. The event occurred in (b)(6) 2018. She was evaluated by a physician; however, the area was not x-rayed. She stated that she has stopped using the dexcom system in (b)(6) 2019. At the time of contact, the patient was doing okay. No data or product was provided for investigation. Confirmation of the allegation was undetermined. The probable cause could not be determined. No additional patient or event information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2019-029691 |
| MDR Report Key | 8457328 |
| Report Source | CONSUMER |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-03-27 |
| 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 | |
| Date Received | 2019-03-27 |
| Model Number | 9500-27 |
| Catalog Number | STS-MC-001 |
| 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 | 1. Other | 2019-03-27 |