BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SENSOR COMFORT TEST STRIPS

    MDR report key: 2071930 · Received April 28, 2011

    Report

    Report Number
    1823260-2011-02301
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 12, 2011
    Report Date
    August 16, 2011
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON A ROCHE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 1. 220 MG/DL (ADVANTAGE) AND 110 MG/DL (DOCTOR'S METER) 2. 230 MG/DL (ADVANTAGE) AND 115 MG/DL (DOCTOR'S METER) SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. CUSTOMER PURCHASED STRIPS WHILE IN SRI LANKA, AND READINGS WERE TAKEN ON CUSTOMER'S METER AND DOCTOR'S METER WHILE IN SRI LANKA. CUSTOMER DOUBLED HIS AMOUNT OF MEDICATION (MINIDIAB TABLET) DUE TO THE METER READINGS; HOWEVER, THE CUSTOMER HAD NO ILL EFFECTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® SENSOR COMFORT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 451192

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR MINIDIAB 3X DAILY