FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK AVIVA TEST STRIPS
MDR report key: 1780551
·
Received September 19, 2007
Report
- Report Number
- 1823260-2007-08192
- Event Type
- Malfunction
- Date Received
- September 19, 2007
- Date of Event
- August 20, 2007
- Report Date
- September 19, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
REPORTED STATED THAT BLOOD GLUCOSE VALUES OBTAINED ON THE AVIVA SYSTEM WERE UP TO 5.0 MMOL/L GREATER THAN VALUES OBTAINED ON A LAB INSTRUMENT. NO ACTUAL VALUES OBTAINED ON EITHER DEVICE WERE PROVIDED. ADDITIONALLY, THE TIME BETWEEN SAMPLE COLLECTIONS WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. QUALITY CONTROL TESTING WAS REPORTEDLY PERFORMED ON THE AVIVA SYSTEM AND VALUES WERE WITHIN ACCEPTABLE RANGES. 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 | LFR | ROCHE DIAGNOSTICS | 300601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |