MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-25 for DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM STS-7K-004 manufactured by Dexcom, Inc..
[185776308]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185776309]
It was reported that broken sensor wire occurred. The sensor was inserted into the abdomen. No product was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-28624 |
| MDR Report Key | 9879066 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | ASHLEY SPOTO |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2000200 |
| Manufacturer G1 | DEXCOM, INC. |
| Manufacturer Street | 6340 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | MDS |
| Date Received | 2020-03-25 |
| Model Number | NI |
| Catalog Number | STS-7K-004 |
| Lot Number | 5256604 |
| Device Expiration Date | 2020-03-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM, INC. |
| Manufacturer Address | 6340 SEQUENCE DRIVE SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |