FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1110143
·
Received August 14, 2008
Report
- Report Number
- 1823260-2007-05127
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- May 29, 2007
- Report Date
- June 12, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED DISCREPANT BLOOD GLUCOSE BACK TO BACK VALUES OF HI, 572, AND 252 MG/DL WHEN TESTS WERE PERFORMED 1 MINUTE APART ON THE ADVANTAGE SYSTEM. NO REPORT OF ACTIONS OR TREATMENT. 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 TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 549535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | ATENOLOL - 20MG ONCE DAILY| PLAVIX - 75MG ONCE DAILY| LIPITOR 20MG ONCE DAILY| METFORMIN 4YRS 1000MG ONCE DAILY| CASODEX 6MOS 50MG ONCE DAILY |