FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6491151
·
Received April 13, 2017
Report
- Report Number
- 2531779-2017-07642
- Event Type
- Malfunction
- Date Received
- April 13, 2017
- Report Date
- March 22, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- UDI-DI
- 10840406100082
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/22/2017 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREADS TO THE CASE SEAL LEFT OF THE GRIP PAD, AND FROM BELOW THE GRIP PAD TO THE CASE SEAL. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/22/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271130 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION | 10840406100082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |