FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1063593
·
Received June 20, 2008
Report
- Report Number
- 1823260-2008-04882
- Event Type
- Malfunction
- Date Received
- June 20, 2008
- Date of Event
- June 17, 2008
- Report Date
- June 20, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED METER RESULTS OF 426 MG/DL AND 175 MG/DL WITHIN 10 MINUTES ON THE INFORM SYSTEM. CUSTOMER REPORTED NO PATIENT SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 | 549731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | PROCHLOPRERAZINE 26MG/DAY - 4 MONTHS| LISINOPRIL 40MG/DAY - 11 MONTHS| NIFEDIPINE 90MG/DAY - 11 MONTHS| LEXAPRO - 5MG/DAY| CARBAMAZEPINE 100MG/DAY - 4 MONTHS| ACETAMINOPHEN 325MG/DAY - 5 MONTHS| FLOMAX CAP 0.4MG/DAY - 11 MONTHS| BISACODYL 5MG/DAY - 11 MONTHS| ASPIRIN 81MG/DAY - 11 MONTHS| FUROSEMIDE - 2 MONTHS| CERTAGEN - 10 MONTHS| GLIPIZIDE - 10MG/DAY| POTASSIUM CHLORIDE - 10MEQ/DAY - 11 MONTHS| LIPITOR 10MG/DAY - 11 MONTHS| ARICEPT 5MG/DAY - 2 MONTHS| NAPROXEN 250MG/DAY - 11 MONTHS |