BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1810305 · Received August 20, 2010

    Report

    Report Number
    1823260-2010-05001
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE CLIPS WOULD NOT ADVANCE AND WOULD NOT CLOSE. ANOTHER DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 229 MG/DL AND 119 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302543

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR JANUVIA| VICODIN| MULTIVITAMIN