BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2781231 · Received October 10, 2012

    Report

    Report Number
    1823260-2012-05068
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 438 MG/DL AND 145 MG/DL WITHIN 10 MINUTES. 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 303520

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR ASPIRIN| SIMVASTATIN| RANITIDINE| ISOSORBIDE| LANTUS| WARFARIN| CLOPIDOGREL| NOVOLIN R| GABAPENTIN| METOPROLOL| DILTIAZEM