FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 1980103
·
Received February 7, 2011
Report
- Report Number
- 1823260-2011-00637
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 22, 2011
- Report Date
- February 14, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS OF 534 MG/DL AND 63 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 | ROCHE DIAGNOSTICS | NA | 551428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 062 YR | IRON| GLIMEPIRIDE| AVAPRO| LASIX| KLOR-CON| DOXAZOSIN| DICLOFENAC| SIMVASTATIN| WARFARIN| HUMULIN| CARVEDILOL| LANTUS| MULTIVITAMIN |