FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 4192365
·
Received October 22, 2014
Report
- Report Number
- 1823260-2014-08140
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 25, 2014
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 REPORTED THAT THERE WERE LINES GOING ACROSS THE DISPLAY OF THE BLOOD GLUCOSE MONITOR. 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 |
|---|---|---|---|---|---|---|---|
| 671731 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |