FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2070681
·
Received April 27, 2011
Report
- Report Number
- 1823260-2011-02276
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 7, 2011
- Report Date
- June 13, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR STRIP LOT 551477. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR STRIP LOT 551480.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 500 MG/DL (STRIP LOT 551477) AND 130 MG/DL (STRIP LOT 551480) RESULTS WERE TAKEN WITH DIFFERENT STRIP LOTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 | ROCHE DIAGNOSTICS | NA | 551477 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 069 YR | ABILIFY| LISINOPRIL| AMLODIPINE| DIOVAN| IBUPROFEN| TRAZODONE| NOVOLIN R| NOVOLIN R NPH| PRAVASTATIN |