FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK AVIVA TEST STRIPS
MDR report key: 1123873
·
Received August 15, 2008
Report
- Report Number
- 1823260-2008-06235
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 15, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
REPORTER STATED THAT PATIENT OBTAINED BACK-TO-BACK BLOOD GLUCOSE RESULTS OF 14.4 MMOL/L, 25.0 MMOL/L, AND 10 MMOL/L ON THE AVIVA SYSTEM. REPORTER INDICATED THAT PATIENT DID NOT MODIFY THERAPY BASED ON THESE RESULTS. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - NA | NBW | ROCHE DIAGNOSTICS | 301078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |