BEUDAMED
    FDA Adverse Event Summary report: N

    INTEGRA

    MDR report key: 1852636 · Received September 30, 2010

    Report

    Report Number
    1852636
    Date Received
    September 30, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGIST OPERATING THE INTEGRA BEGAN TO NOTICE THAT CALCIUM RESULTS ON SEVERAL PATIENTS IN A ROW WERE ELEVATED. QC (BOTH LEVELS) WAS PERFORMED AT THAT TIME; BOTH WERE UNACCEPTABLY HIGH. MORNING QC HAD BEEN FINE. THE REAGENT WAS PULLED OFF THE INSTRUMENT AND A FRESH REAGENT CARTRIDGE WAS LOADED; QC WAS ACCEPTABLE. THE TECHNOLOGIST REPEATED 18 PATIENT SAMPLES AND HAD TO MAKE CORRECTIONS AND NOTIFY PROVIDER OF THE 5 PATIENTS WHOSE RESULT WAS CLINICALLY DIFFERENT. THE ISSUE SEEMED TO OCCUR WHEN THE NUMBER OF TESTS LEFT IN THE CARTRIDGE GOT LOW.====================== MANUFACTURER RESPONSE FOR CLINICAL LAB CHEMISTRY INSTRUMENT, INTEGRA======================ROCHE HAS SENT US A NEW LOT OF REAGENT. WE HAVE NOT ANY ISSUES WITH THE NEW LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA CLINICAL LAB CHEMISTRY INSTRUMENT JJE ROCHE DIAGNOSTICS 400 PLUS CALCIUM 300 626019-01

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR
    2 52 YR
    3 84 YR
    4 58 YR
    5 74 YR
    6 74 YR