FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 3911900
·
Received July 3, 2014
Report
- Report Number
- 1823260-2014-04867
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- March 23, 2014
- Report Date
- July 3, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTED THERE IS A BLACK LINE IN THE MIDDLE OF THE DISPLAY OF THE METER. DURING EVALUATION, IT WAS OBSERVED THAT THE LOCATION OF THE LINES ON THE DISPLAY DO DISTORT THE LAST DIGIT OF THE RESULT DURING THE SIMULATION TEST; THEREFORE, MISINTERPRETATION IS POSSIBLE. NO ADVERSE EVENT REPORTED. METER WAS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389358 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |