FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 855341
·
Received March 2, 2007
Report
- Report Number
- 1823260-2007-01810
- Event Type
- Malfunction
- Date Received
- March 2, 2007
- Date of Event
- February 11, 2007
- Report Date
- March 2, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED A RESULT OF 74MG/DL ON THE ADVANTAGE TEST SYSTEM AND APPROX 40MG/DL ON THE PARAMEDIC'S DEVICE. NO ACTION WAS TAKEN BASED ON DEVICE RESULT. CUSTOMER RECEIVED A GLUCOSE IV. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. INFORMATION SUGGESTS COMPARISON WAS PERFORMED IN THE HOME. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549531, EXP 03/31/2008, CAT/203065.
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 | * | 549531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | DILTIAZEM 240MG 1X A DAY| METOPROLOL TARTRATE 50 MG 2X A DAY| FUROSEMIDE 40MG 1X A DAY| OMEPRAZOLE 20MG 1X A DAY| ITCH PILL AS NEEDED W/ ITCHING RASH| ACETAMINOPHEN 2 TABLETS UP TO 4X DAY| LISINOPRIL 20MG 1X A DAY| 70/30 INSULIN - 37 UNITS AM AND 36 UNITS PM| GLYBURIDE 2 5MG PILLS 2X A DAY| ASPIRIN 2 81MG PILLS 1X A DAY |