BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3505961 · Received December 9, 2013

    Report

    Report Number
    1823260-2013-07448
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    January 1, 2011
    Report Date
    January 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES ON (B)(6) 2013: 368 MG/DL AND 141 MG/DL. CUSTOMER ALSO REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES ON (B)(6) 2013: 546 MG/DL AND 199 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO INFORMATION TO REASONABLY SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637230 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551995

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR STEROIDS| NOVOLOG| CELEBREX| LANTUS| METHOTREXATE