MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-13 for 9500-45 STS-OR-001 manufactured by Dexcom, Inc..
[185712403]
(b)(4). Event problem and evaluation codes: patient was unable to identify device issue therefore a more specific code could not be selected.
Patient Sequence No: 1, Text Type: N, H10
[185712404]
It was reported that replace sensor now alert occurred. Data was evaluated and the allegation was not confirmed. A probable cause could not be determined. However an early sensor expiration due to potential patient misuse was found on (b)(6) 2020. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[186463078]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186463079]
It was reported that replace sensor now alert occurred. Data was evaluated and the allegation was not confirmed. A probable cause could not be determined. However an early sensor expiration due to potential patient misuse was found on (b)(46) 2020. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004753838-2020-024730 |
MDR Report Key | 9830073 |
Report Source | CONSUMER |
Date Received | 2020-03-13 |
Date of Report | 2020-03-19 |
Date of Event | 2020-02-21 |
Date Mfgr Received | 2020-03-19 |
Date Added to Maude | 2020-03-13 |
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 |
Generic Name | CONTINUOUS GLUCOSE MONITOR |
Product Code | MDS |
Date Received | 2020-03-13 |
Model Number | 9500-45 |
Catalog Number | STS-OR-001 |
Lot Number | NI |
Operator | LAY USER/PATIENT |
Device Availability | * |
Device Age | DA |
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 | 2020-03-13 |