BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2191958 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04200
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 17, 2011
    Report Date
    September 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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE ADVANTAGE SUSPECT DEVICE SYSTEM USED. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(4) FOR THE AVIVA SUSPECT DEVICE SYSTEM USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 264 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 110 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 551494

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR VICTOZA| LISINOPRIL| LEVEMIR| METFORMIN| GLUCOPHAGE| SIMVASTATIN| BAYER ASPIRIN| CARVEDILOL