FDA Adverse Event
Injury
Summary report: N
ANIMAS VIBE
MDR report key: 6042018
·
Received October 19, 2016
Report
- Report Number
- 2531779-2016-29131
- Event Type
- Injury
- Date Received
- October 19, 2016
- Report Date
- September 26, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYC
- UDI-DI
- 10840406100044
- PMA / PMN Number
- P130007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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.
Description of Event or Problem · 1
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED AN INACCURATE DELIVERY ISSUE, AND THAT THE PATIENT HAD A BLOOD GLUCOSE OF 500 - 600 MG/DL. ANIMAS HAS MADE MULTIPLE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE/CONTRIBUTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691623 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYC | ANIMAS CORPORATION | 10840406100044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Life Threatening |