FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 3912129
·
Received July 3, 2014
Report
- Report Number
- 1823260-2014-04873
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- January 31, 2014
- Report Date
- August 21, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED THE METER HAS A BLACK LINE THROUGH THE CENTER OF THE SCREEN. REQUESTED RETURN OF THE ALLEGED METER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389372 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |