BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2914390 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00285
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 22, 2012
    Report Date
    February 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. STRIPS NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULT OF 140 MG/DL, PROFESSIONAL SYSTEM RESULT OF 140 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19752 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1