BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 1833798 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05420
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON TWO PT SAMPLES. BOTH THE PT SAMPLES WERE (B)(6) FOR (B)(6) ON THE ADVIA CENTAUR. THE LABORATORY PRACTICE IS TO CONFIRM (B)(6) SAMPLES WITH THE (B)(6) ASSAY. THE CUSTOMER REPEATED TESTING FOR THE PT SAMPLES ON A DIFFERENT METHOD AND THE RESULTS FOR (B)(6) WERE (B)(6). THE RESULTS FOR THE (B)(6) ASSAY WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Description of Event or Problem · 1

    CALLER REPORTED ACTIVE S SYSTEM BLOOD GLUCOSE RESULTS: 1:47 PM 149 MG/DL 1:49 PM 161 MG/DL 1:50 PM 160 MG/DL 1:57 PM 82 MG/DL REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 13 MG/DL, 168 MG/DL AND 148 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23421031

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR PRENATAL VITAMINS| GLYBURIDE