MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for ANIMAS VIBE manufactured by Animas Llc.
[113525906]
The pump has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
[113525907]
On (b)(6) 2018, the reporter contacted animas, alleging a display (line through display with moisture) issue. It was alleged there was moisture behind the display. There was no indication that the device caused or contributed to an adverse event. This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.
Patient Sequence No: 1, Text Type: D, B5
[117023682]
Device evaluation: the device has been returned and evaluated by product analysis on 17-jul-2018 with the following findings: during investigation, the pump powered up to a fully functional display. The alleged line through the display was unable to be duplicated. Visible moisture was found in the battery compartment with a leak. The pump was opened to find moisture corrosion on the battery housing. No moisture was found on the display.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531779-2018-12366 |
| MDR Report Key | 7665497 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-27 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-07-05 |
| 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 | POY |
| Date Received | 2018-07-05 |
| Returned To Mfg | 2018-07-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-07-05 |