FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2001440
·
Received February 25, 2011
Report
- Report Number
- 1823260-2011-01044
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 18, 2011
- Report Date
- April 21, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 REPORTEDLY RECEIVED RESULTS OF 230 MG/DL AND 106 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. CUSTOMER STATES SHE HAD A HEADACHE WHEN THE REPORTED RESULTS WERE OBTAINED. CUSTOMER SELF TREATED WITH WATER. NO ADVERSE EVENT 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 | ROCHE DIAGNOSTICS | NA | 551414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR | GLYBURIDE 2 TABLETS DAILY| Q-PAP 1 TABLET DAILY| "LEVOPREMASOL" DAILY| BENAZEPRIL 1 TABLET DAILY| "LEVOLTIROPSINE" DAILY| ASPIRIN| METFORMIN 2 TABLETS DAILY| PRAVASTATIN 1 TABLET DAILY |