MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-10 for DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-05 STT-GL-004 manufactured by Dexcom, Inc..
[182804331]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182804332]
It was reported that signal loss over one hour occurred. No product or data 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 | 3004753838-2020-023559 |
| MDR Report Key | 9813961 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-05-09 |
| Date Added to Maude | 2020-03-10 |
| 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 | MS ASHLEY SPOTO |
| 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 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | CONTINUOUS GLUCOSE MONITOR |
| Product Code | MDS |
| Date Received | 2020-03-10 |
| Model Number | 9438-05 |
| Catalog Number | STT-GL-004 |
| Lot Number | 5254739 |
| Device Expiration Date | 2019-12-21 |
| 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 | 2020-03-10 |