FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1760863
·
Received July 13, 2007
Report
- Report Number
- 1823260-2007-06049
- Event Type
- Malfunction
- Date Received
- July 13, 2007
- Date of Event
- January 22, 2007
- Report Date
- July 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AND TESTING 147MG/DL ON THE ADVANTAGE SYSTEM. CUSTOMER DRANK ORANGE JUICE AND ATE A SANDWICH BASED ON HIS SYMPTOMS. WITHIN A FEW MINUTES, CUSTOMER TESTED 149MG/DL ON THE SAME ADVANTAGE SYSTEM. THE PARAMEDICS WERE CALLED AND CUSTOMER WAS REPORTEDLY UNCONSCIOUS WHEN THEY ARRIVED APPROXIMATELY 10 MINUTES LATER. CUSTOMER WAS TESTED ON THE PARAMEDIC'S DEVICE, BUT STATES, THE RESULT WAS TOO LOW TO REGISTER ON THEIR METER. CUSTOMER WAS SUBSEQUENTLY TREATED WITH ORAL GLUCOSE AND TRANSPORTED TO THE HOSPITAL. NO TREATMENT INFORMATION PROVIDED FROM CUSTOMER'S HOSPITAL STAY. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, STRIPS ARE NOT AVAILABLE FOR RETURN.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | GLUCOPHAGE 2000MG/DAY - UNK DURATION| GLYBURIDE 5MG/DAY - UNK DURATION |