BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEIVED ONE METER SN 53533070744, ONE VIAL OF STRIP LOT# 303401 EXP. 11-2012 WI

    MDR report key: 2495657 · Received March 19, 2012

    Report

    Report Number
    1823260-2012-01503
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 19, 2012
    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
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 204 MG/DL AND 108 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. 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 RECEIVED ONE METER SN 53533070744, ONE VIAL OF STRIP LOT# 303401 EXP. 11-2012 WI BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303307

    Patients

    Seq Age Sex Outcome Treatment
    1 089 YR