BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREA PREALBUMIN

    MDR report key: 6913239 · Received October 4, 2017

    Report

    Report Number
    1823260-2017-02191
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 13, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZJ
    PMA / PMN Number
    K972638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINED SAMPLE WAS FOUND TO BE TURBID. THE SAMPLE WAS EVALUATED USING IMMUNOELECTROPHORESIS AND WAS FOUND TO CONTAIN POLYCLONAL IGG AND IGM-KAPPA. THE SAMPLE WAS ASSUMED TO BE TURBID DUE TO THE PRESENCE OF THESE ABNORMAL IMMUNOGLOBULINS. AFTER IMMUNOABSORPTION OF THE IGG WITH PROTEIN G, THE PREA MEASURING RESULTS ON C502 WENT DOWN. IT IS ASSUMED THAT THE ROOT CAUSE FOR THE FALSELY ELEVATED RESULTS IS CAUSED BY IGM-KAPPA AND/OR BY TURBIDITY DUE TO HIGH IGG CONCENTRATION. GAMMOPATHY, IN PARTICULAR TYPE IGM (B)(4), MAY CAUSE UNRELIABLE RESULTS AS STATED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR PREA PREALBUMIN (PREA) ON A COBAS 8000 C 502 MODULE (C502). IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED AS 32 MG/DL WHEN TESTED ON THE C502 ANALYZER. WHEN THE SAMPLE WAS TESTED ON AN OLYMPUS AU480 ANALYZER USING THE N-ASSAY TIA PREALBUMIN NITTOBO (MADE IN (B)(6)), IT RESULTED AS 3.5 MG/DL. IT IS UNKNOWN WHICH VALUE IS CORRECT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE C502 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692900 PREA PREALBUMIN PREALBUMIN IMMUNOLOGICAL TEST SYSTEM JZJ ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR