MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-12 for DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MT20649-3 STR-JP-001 manufactured by Dexcom, Inc..
[183131881]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183131882]
It was reported that error icon displayed 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
[188146965]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188146966]
It was reported that error icon displayed occurred. The product was evaluated. An external visual inspection was performed and passed. Charge and boot test was performed and passed. The log was downloaded and reviewed finding no errors related to the complaint. The allegation was not confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753838-2020-024300 |
| MDR Report Key | 9824449 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Model Number | MT20649-3 |
| Catalog Number | STR-JP-001 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-12 |