FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 838406
·
Received February 13, 2007
Report
- Report Number
- 1823260-2007-01302
- Event Type
- Malfunction
- Date Received
- February 13, 2007
- Date of Event
- January 30, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- KO10362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT PRODUCT IS COMFORT CURVE TEST STRIPS, LOT 49512, EXP: 02/29/2008, CAT/2030373.
Description of Event or Problem · 1
CUSTOMER TESTING ON ACCU-CHEK ADVANTAGE SYSTEM (ADVANTAGE METER, ACCU-CHEK COMFORT CURVE TEST STRIPS LOT# 2030373, EXP DATE 02/29/2008). CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER 5 MINUTES APART WITH BLOOD GLUCOSE RESULTS OF 380 MG/DL AND 154 MG/DL. NO CONTROLS WERE RAN. CUSTOMER DID NOT TREAT BASED ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR SUSPECT PRODUCT, AND A 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 | * | 549512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | ATENOLOL-25MG/ONCE A DAY| GLYBURIDE-5MG/TWICE A DAY| SIMVASTATIN-80MG/ONCE A DAY| BABY ASPIRIN-81MG/ONE A DAY |