BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2001393 · Received February 25, 2011

    Report

    Report Number
    1823260-2011-01040
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULT OF 68 MG/DL AT 12:20 PM, HAD NO SYMPTOMS, ATE A HAMBURGER, STRING BEANS, AND (B)(6) CHEESE. TEST RESULT AT 12:49 PM WAS 423 MG/DL. RETEST RESULT WITHIN 10 MINUTES WAS 134 MG/DL. REPORTED NO ADVERSE EVENT. 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 302964

    Patients

    Seq Age Sex Outcome Treatment
    1 LEVOTHYROXINE 1XDAY| LANTUS 1XDAY| HUMALOG 3XDAY