BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1801422 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04836
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 425 MG/DL, 184 MG/DL, AND 182 MG/DL, WITHIN 5 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 4.4, LAB: 3.4. INRATIO: 3.7, LAB: 3.4. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 4.4, INR: 3.7.

    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 302672

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR COREG 2XDAY| PACEMAKER| PACERONE 1XDAY| RIGHT KNEE REPLACEMENT| POTASSIUM 2XDAY| LASIX| HIP REPLACEMENT| AMARYL