FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 5229856
·
Received November 17, 2015
Report
- Report Number
- 3011393376-2015-05129
- Event Type
- Malfunction
- Date Received
- November 17, 2015
- Date of Event
- October 1, 2015
- Report Date
- August 5, 2025
- Manufacturer
- SANMINA CORPORATION
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6) WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS ALLEGED THAT THE TREATMENT RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR COULD BE INACCURATE. NO ADVERSE EVENT WAS REPORTED. THE BLOOD GLUCOSE MONITOR WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760417 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |