BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1853001 · Received October 5, 2010

    Report

    Report Number
    1823260-2010-05883
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 CUSTOMER HAD AVIVA RESULTS OF 19 MG/DL AND 37 MG/DL "IMMEDIATELY AFTER EACH OTHER". CUSTOMER SELF TREATED WITH GATORADE, AND 10 MINUTES AFTER THE READING OF 19, CUSTOMER GOT A READING OF 132 MG/DL. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 LANTUS 1XDAY| HUMALOG 4XDAY