FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1040978
·
Received May 8, 2008
Report
- Report Number
- 1823260-2008-03849
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 21, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULT OF 520 MG/DL ON THE ADVANTAGE SYSTEM AND 121 MG/DL ON PROFESSIONAL METER WITHIN 10 MINUTES. 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 | LFR | ROCHE DIAGNOSTICS | 550051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | BABY ASPIRIN - 81MG 1/DAY| RANITIDINE - 150MG 2/DAY| ATENOLOL - 50MG 2/DAY| PLAVIX - 75MG 1 EVERY OTHER DAY| B12 - 2MG 1/DAY| "TRIANT" HCTZ - 37.5/25 1/DAY |