FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 845498
·
Received March 1, 2007
Report
- Report Number
- 1823260-2007-01755
- Event Type
- Malfunction
- Date Received
- March 1, 2007
- Date of Event
- January 23, 2007
- Report Date
- March 1, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- KO10362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT PRODUCT IS THE COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER TESTING USING ACCU-CHEK ADVANTAGE SYSTEM. REPORTER STATES CUSTOMER RAN BACK TO BACK RESULTS ON THE SAME METER WITHIN ONE MINUTE WITH RESULTS OF 188MG/DL AND 68MG/DL. CUSTOMER ALSO RAN BACK TO BACK RESULTS ON THE SAME METER WITHIN 5 MINUTES WITH RESULTS OF 418MG/DL AND 89MG/DL. REPORTER RAN CONTROLS AND STATES THEY ARE OUT OF RANGE. LOCATION OF TESTING IS NOT PROVIDED. CUSTOMER STATES HE DID NOT TREAT HIMSELF BASED ON READINGS. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT. ACCU-CHEK ADVANTAGE SYSTEM: METER, ACCU-CHEK COMFORT CURVE TEST STRIPS CAT#2030373, LOT# NOT PROVIDED, EXP DATE# NOT PROVIDED.
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 | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | FUROSEMIDE - 1 YR 40MG/1XDAY| CANDESARTAN - 3 MONTHS 16MG/1XDAY| VYTORIN - 1 YR 10/20TAB/1XDAY| NOVOLIN 70/30 3 YRS 100UNITS/NIGHT| AMLODIPINE - 1 YR 10MG/1XDAY| ATENOLOL - 3 YRS 100MG/2XDAY| NOVOLIN 70/30 3 YRS 40UNITS/MORNING| NOVOLOG 10UNITS/AFTER |