FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 3931459
·
Received July 14, 2014
Report
- Report Number
- 1823260-2014-05161
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- May 5, 2014
- Report Date
- July 14, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED THERE IS A THIN LINE DOWN THE DISPLAY OF THE BLOOD GLUCOSE MONITOR. NO ADVERSE EVENT WAS REPORTED. THE PRODUCT WAS RETURNED AND EVALUATED, AND IT WAS FOUND THE LINE COULD CAUSE MISINTERPRETATION OF THE THERAPY INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409576 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 046 YR |