FDA Adverse Event
Injury
Summary report: N
ANIMAS VIBE
MDR report key: 6996383
·
Received November 2, 2017
Report
- Report Number
- 2531779-2017-25636
- Event Type
- Injury
- Date Received
- November 2, 2017
- Report Date
- October 10, 2017
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- OYB
- UDI-DI
- 10840406100181
- PMA / PMN Number
- P130007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE 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.
Description of Event or Problem · 1
ON (B)(6) 2017, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT WAS UNCERTAIN WHAT BLOOD GLUCOSE THEY HAD, BUT THAT EMERGENCY SERVICES WERE CALLED. THE PATIENT WAS REPORTEDLY ¿OUT OF IT¿ AND TREATED WITH INTRAVENOUS FLUIDS AND GLUCAGON. THE REPORTER STATED THAT THE PATIENT HAD ALTERED THE PUMP¿S BASAL SETTINGS PRIOR TO THE EVENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT AS A RESULT OF ADJUSTING THE PUMP¿S BASAL RATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775174 | ANIMAS VIBE | INSULIN INFUSION PUMP | OYB | ANIMAS CORPORATION | 10840406100181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Life Threatening| R |