FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 1973062
·
Received January 28, 2011
Report
- Report Number
- 1823260-2011-00505
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- October 26, 2010
- Report Date
- May 18, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THE DEVICE WAS LABELED AND CONFIGURED FOR MG/DL. DURING INVESTIGATION, IT WAS CONFIRMED THAT THE METER READS NOW IN MMOL/L.
Description of Event or Problem · 1
CALLER REPORTED A MG/DL AVIVA COMBO METER DISPLAYED E57, AND SINCE THAT TIME, THE DEVICE HAS BEEN DISPLAYING RESULTS IN MMOL/L. NO ADVERSE EVENT REPORTED. THE DEVICE WAS RETURNED, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 040 YR |