FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1512479
·
Received October 15, 2009
Report
- Report Number
- 1823260-2009-07185
- Event Type
- Malfunction
- Date Received
- October 15, 2009
- Date of Event
- July 6, 2009
- Report Date
- October 15, 2009
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- 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 REC'D RESULTS OF 300-400 MG/DL ON THE ADVANTAGE SYSTEM AND 150-190 MG/DL ON PROFESSIONAL DEVICE WITHIN 10 MINUTES OF EACH OTHER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | VICODIN - 3 MONTHS| MULTIVITAMIN - 1 MONTH| VITAMIN D - 1 WEEK| LANTUS - 6 YEARS| MELATONIN - 5 YEARS| CELLCEPT - 2 MONTHS| PROGRAF - 3 MONTHS| SEPTRA - 3 MONTHS| FAMOTIDINE - 12 YEARS| LORAPEPAM - 2 MONTHS| TRAZODONE - 6 YEARS| LYRICA - 4 YEARS| FLURAZEPAM - 6 YEARS| HUMALOG - 8 YEARS| PREDNISONE - 3 MONTHS| VALCYTE - 3 MONTHS |