BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE

    MDR report key: 7142245 · Received December 21, 2017

    Report

    Report Number
    MW5074195
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    December 20, 2017
    Manufacturer
    ROCHE
    Product Code
    DLJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BEGINNING IN (B)(6) 2017 THROUGH (B)(6) 2017, THERE WERE 5 INSTANCES WHERE A SET OF 5 SAMPLES APPEARED TO BE MISSING, BUT WERE FOUND ON THE ROCHE MPA. IN WORKING WITH THE VENDOR IT WAS EVENTUALLY DETERMINED THAT SINCE THE LAB HAS 2 MPA INSTRUMENTS THAT RACKS FROM MPA 1 WERE BEING USED ON MPA2. THESE RACKS ARE IDENTICAL INCLUDING THE BAR CODE NUMBERS WITH THE EXCEPTION OF A GREEN STICKER FOR MPA. WHEN THE SECOND RACK WITH THE SAME BAR CODE NUMBER IS INTRODUCED TO THE ANALYZER AND THE FIRST RACK WITH THE SAME NUMBER IS CURRENTLY BEING PROCESSED, THE ANALYZER WILL PRODUCE AN ERROR MESSAGE THAT INDICATES "RACK AND POS IS ALREADY OCCUPIED BY ANOTHER SAMPLE." THE INSTRUMENT ALLOWS THE OPERATOR TO OVERRIDE THE ERROR AND RE-INTRODUCE THE RACK. THE INSTRUMENT THAN DISASSOCIATES THE FIRST SET OF PT DEMOGRAPHICS AND REPLACES IT WITH THE SECOND SET OF PT DEMOGRAPHICS, THEREBY TESTING THE 1ST SET OF SAMPLES AND APPLYING THE SECOND SET OF PT DEMOGRAPHICS TO THE RESULT. THIS CAUSE 22 RESULTS TO BE REPORTED ON THE INCORRECT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920465 ROCHE MPA (MYCOPHENOLIC ACID ASSAY) DLJ ROCHE MPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other