BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 7319958 · Received March 7, 2018

    Report

    Report Number
    1823260-2018-00666
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    January 9, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE WAS UPDATED. THE CUSTOMER BEGAN TO QUESTION THE PROLACTIN III RESULTS WHEN THEY SWITCHED FROM THE COBAS 8000 E 602 MODULE TO THE E801 MODULE. A METHOD COMPARISON WAS PERFORMED BETWEEN A COBAS E801 MODULE AND AN E602 MODULE AT THE INVESTIGATION SITE. REAGENT LOT 172258 WAS USED WITH THE E801 MODULE AT THE INVESTIGATION SITE. CALIBRATION AND QC WERE ACCEPTABLE. THE CUSTOMER SUBMITTED THE 40 PATIENT SAMPLES FOR INVESTIGATION. THE RESULTS FROM THE INVESTIGATION SHOW EXCELLENT COMPARABILITY BETWEEN THE E602 MODULE AND E801 MODULE. BASED ON THE INVESTIGATION RESULTS, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER IS QUESTIONING RESULTS FOR MULTIPLE PATIENTS TESTED FOR ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E801 MODULE. THE CUSTOMER COLLECTED 40 PATIENT SAMPLES THAT HAD BEEN TESTED ON THE E801 MODULE AND REPEATED THE SAMPLES BY THE ABBOTT ARCHITECT METHOD. BASED ON THE DATA PROVIDED, THE RESULTS FOR 23 PATIENT SAMPLES WERE DISCREPANT. THE INITIAL RESULTS FROM THE E801 MODULE HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS WITH GENDER AND AGE. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165796 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA 172258

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR