FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK AVIVA TEST STRIPS
MDR report key: 1052264
·
Received May 6, 2008
Report
- Report Number
- 1823260-2008-03763
- Event Type
- Malfunction
- Date Received
- May 6, 2008
- Date of Event
- April 20, 2008
- Report Date
- May 6, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 93MG/DL AND 174MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | METFORMIN - 4 MONTHS 1000MG/DAY| PROTONIX - 11 MONTHS 40MG/DAY| BYETTA - 6 MONTHS 20MCG/DAY| ECOTRIN - 11 MONTHS 81MG/DAY| HUMULIN 70/30 - 70 UNITS/DAY| ISOSORBIDE - 11 MONTHS 30MG/DAY| THYROID MEDICATION-UNK. NAME - 1MG/DAY| DIOVAN HCT - 8 YEARS| METOPROLOL - 12 YEARS 50MG/DAY |