BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2822231 · Received November 7, 2012

    Report

    Report Number
    1823260-2012-05641
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    July 20, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE OBTAINED ON A PATIENT USING THE INFORM SYSTEM WITHIN 10 MINUTES: 417 MG/DL AND 79 MG/DL (7 MINUTES), 79 MG/DL AND 383 MG/DL (4 MINUTES). SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. READING OF 79 MG/DL WAS TAKEN ONLY ONCE; NO REPEAT OF READINGS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, STRIPS HAVE BEEN USED UP AND WILL NOT BE RETURNED. 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 551742

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR LANTUS 2X DAILY| HUMALOG 3X DAILY WITH MEALS, 1X NIGHTLY