BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1191522 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07183
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR ADVANTAGE SYSTEM 1. PLEASE SEE MEDWATCH WITH A1 PATIENT FOR REPORT ON ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 299 MG/DL USING ADVANTAGE SYSTEM 1, 145 MG/DL USING ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 CORP. 549928

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR FEXOFENADINE HCL: 180 MG/DAY - 3-4 YRS| GLUCOPHAGE/METFORMIN: 2000 MG - 15 YRS| TRICOR: 160 MG/DAY - "SEVERAL YRS"| GLUCOSAMINE/CONDROITEN/NSM:1500MG/DAY-"SEVERAL YRS| FISH OIL: "SEVERAL YRS"| CENTRUM SILVER: "SEVERAL YRS"| LEVOXYL: 88 MCG/DAY - 20 YRS| DIOVAN HCT: 160/12.5 MG/2/DAY - "SEVERAL YRS"| PRILOSEC: 40 MG/DAY - 2-3 YRS| AMLODIPINE: 5 MG/DAY - 1 YR| LIPITOR P-D: 40 MG/DAY - 3 YRS| BYETTA: 5 MCG/DAY| ASPIRIN: 81 MG/DAY - "SEVERAL YRS"| CALCIUM/VITAMIN D: "SEVERAL YRS"