BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1960372 · Received January 13, 2011

    Report

    Report Number
    1823260-2011-00224
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 31, 2010
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 303159, EXPIRATION DATE 03/31/2012). (B)(6).

    Description of Event or Problem · 1

    CALLER STATES PATIENT RECEIVED RESULTS OF 154 MG/DL ON AVIVA SYSTEM 1 AND 74 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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 303159

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR LIPITOR| "AMLODBENAZP"| NAMENDA| ASPIRIN| DETROL| WALKER| ARICEPT