FDA Adverse Event
Malfunction
Summary report: N
ANIMAS VIBE
MDR report key: 6556500
·
Received May 10, 2017
Report
- Report Number
- 2531779-2017-09929
- Event Type
- Malfunction
- Date Received
- May 10, 2017
- Report Date
- April 21, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- UDI-DI
- 10840406100259
- PMA / PMN Number
- P130007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 04/21/2017 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT IS CRACKED. (B)(6).
Description of Event or Problem · 1
THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CRACKED COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 04/21/2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339374 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION | 10840406100259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Life Threatening |