FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1747065
·
Received August 1, 2007
Report
- Report Number
- 1823260-2007-06683
- Event Type
- Malfunction
- Date Received
- August 1, 2007
- Date of Event
- July 19, 2007
- Report Date
- August 1, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 61, 56, 213, 250, 245, 266, 254, AND 270 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO REPORT OF ANY ACTIONS TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING DEVICE - LFR | LFR | ROCHE DIAGNOSTICS | 549632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | ATENOLOL - 25MG TWICE DAILY| AMITRIPTYLINE - 100MG ONCE DAILY| NOVOLOG - SLIDING SCALE| PRAVACHOL - 10MG ONCE DAILY| DIGITEK - 0.25MG ONCE DAILY| LASIX - 60MG ONCE DAILY| PREDNISONE - 15MG ONCE DAILY| LEVOTHYROXINE - 1.075MCG MYLAN ONCE DAILY| LANTUS - 30&70UNITS EACH DOSE ONCE DAILY| LISINOPRIL - 10MG ONCE DAILY| GUAIFENESIN L.A. - 600MG 2 TABS TWICE DAILY| LYRICA - 25 & 75MG EACH DOSE ONCE DAILY |