BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1893777 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06650
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 5, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(6).

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A RESULT OF 40 MG/DL ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 120 MG/DL ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 302632

    Patients

    Seq Age Sex Outcome Treatment
    1 ATENOLOL| LANTUS| VERAPAMIL