MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for ANIMAS VIBE manufactured by Animas Llc.
[118149774]
The pump has been returned and evaluated by product analysis on 10-aug-2018 with the following findings: the battery compartment was found to be cracked below the bumper pad. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[118149775]
The pump was returned for investigation. Investigation revealed a cracked battery compartment. This report is made based on results of investigation completed on 10-aug-2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531779-2018-15228 |
| MDR Report Key | 7807888 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-10 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-08-22 |
| 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 | KARIN SARGRAD |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 193803428 |
| Manufacturer Country | US |
| Manufacturer Postal | 193803428 |
| Manufacturer Phone | 4843561808 |
| Manufacturer G1 | ANIMAS LLC |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 193803428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 193803428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANIMAS VIBE |
| Generic Name | INSULIN INFUSION PUMP |
| Product Code | OYS |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-08-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANIMAS LLC |
| Manufacturer Address | 200 LAWRENCE DR WEST CHESTER PA 193803428 US 193803428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-22 |