BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AFP ASSAY

    MDR report key: 6940687 · Received October 11, 2017

    Report

    Report Number
    1823260-2017-02269
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOJ
    PMA / PMN Number
    K981282
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE INVESTIGATION STATED THE MEASURED AFP VALUE OF A PATIENT'S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. AFP VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATIONS. THIS INFORMATION IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS AFP ASSAY (AFP) ON A COBAS 8000 E 602 MODULE. THE INITIAL AFP RESULT FROM THE E602 MODULE WAS 15.0 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY AND REPEATED USING THE LIGAND BINDING ASSAY METHOD FROM WAKO AND THE RESULT WAS 5.7 NG/ML. THE CUSTOMER DOES NOT KNOWN WHICH RESULT IS CORRECT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722323 ELECSYS AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER LOJ ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1