FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1032036
·
Received April 21, 2008
Report
- Report Number
- 1823260-2008-03395
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 21, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER STATES THAT SHE FELT HYPERGLYCEMIC AND WENT TO THE PHYSICIAN. SHE OBTAINED THE BLOOD GLUCOSE RESULT OF 280MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE PROFESSIONAL METER RESULT OF 119MG/DL. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 549722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | METFORMIN 500MG/DAY |