FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 1980453
·
Received February 7, 2011
Report
- Report Number
- 1823260-2011-00660
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 22, 2011
- Report Date
- February 25, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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
CUSTOMER REPORTS SHE HAS PASSED OUT AND TESTED 108 MG/DL ON THE COMPLETE SYSTEM USING COMFORT CURVE TEST STRIPS. CUSTOMER'S SPOUSE IMMEDIATELY TESTED HER ON HIS "ONE TOUCH" SYSTEM AND RESULT WAS 31 MG/DL. CUSTOMER WAS TREATED WITH AN INJECTION OF GLUCAGON AND SHE REGAINED CONSCIOUSNESS 10-12 MINUTES LATER. CUSTOMER WAS GIVEN PEANUT BUTTER CRACKERS AND 30 MINUTES LATER SHE TESTED 130 MG/DL ON THE "ONE TOUCH" SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. 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 | ROCHE DIAGNOSTICS | NA | 551190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR | COUMADIN| UNKNOWN INSULIN PUMP| NOVOLOG| SYNTHROID |