BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP IMMUNOASSAY

    MDR report key: 10123507 · Received June 5, 2020

    Report

    Report Number
    1823260-2020-01371
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    January 25, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DISCOVERED PATTERNS OF DISCREPANT RESULTS BETWEEN SERUM AND PLASMA SAMPLES FROM THE SAME BLOOD DRAW OF A GIVEN PATIENT: NEGATIVE RESULTS OR RESULTS BELOW THE CUTOFF VALUE ON SERUM SAMPLES AND POSITIVE RESULTS ON PLASMA SAMPLES. ALSO, THE CONCENTRATIONS OBTAINED FROM PLASMA SAMPLES ARE DEPENDENT ON THE REAGENT LOTS USED FOR TESTING. FURTHER INVESTIGATIONS WERE CONDUCTED AND THE INVESTIGATION COULD NOT IDENTIFY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-CCP IMMUNOASSAY RESULT FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY TO A CLINICIAN. THE CLINICIAN WAS ALERTED OF THE QUESTIONABLE RESULT DUE TO THE RESULT NOT MATCHING THE PATIENT'S CLINICAL PICTURE AND RHEUMATOID FACTOR RESULTS. THE PATIENT'S SERUM SAMPLE WAS TESTED FOR CONFIRMATION. THE PATIENT¿S ANTI-CCP RESULT WITH A PLASMA SAMPLE WAS "WEAK POSITIVE." THE PATIENT¿S ANTI-CCP RESULT WITH A SERUM SAMPLE WAS "NEGATIVE" (<7 IU/ML). THE PATIENT'S SERUM RESULT WAS DETERMINED CORRECT. THE E 601 MODULE SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586917 ELECSYS ANTI-CCP IMMUNOASSAY ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1