BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2863749 · Received December 10, 2012

    Report

    Report Number
    1823260-2012-06197
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 17, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE INFORM SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE ALLEGEDLY OBTAINED ON A PATIENT WITH TWO DIFFERENT INFORM METERS WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL) AND 252 MG/DL. CALLER WAS UNCERTAIN AS TO WHICH INFORM METER WAS USED WITH EACH RESULT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND 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 ROCHE DIAGNOSTICS NA 551705

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR GLUCOSE