BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1860084 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-06018
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 302093, EXPIRATION DATE 03/31/2011). (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) KEPT FOLDING INCORRECTLY. PT IMPACT REMAINS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT RECEIVED RESULTS OF 2.2 MMOL/L ON AVIVA SYSTEM 1 AND 3.3 MMOL/L ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT 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 302093

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR