BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 7333739 · Received March 13, 2018

    Report

    Report Number
    1823260-2018-00799
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 13, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 3 SEPARATE SAMPLES FROM THE SAME PATIENT TESTED FOR ELECSYS PROLACTIN ASSAY ON A COBAS 6000 E 601 MODULE COMPARED TO A CENTAUR ANALYZER. ALL 3 SAMPLES FROM THE SAME PATIENT WERE OBTAINED IN HOURLY INTERVALS ON THE SAME DAY. FOR SAMPLE 1, THE COBAS E601 PROLACTIN RESULT WAS 886 ULU/ML WHILE THE CENTAUR RESULT WAS 611 ULU/ML. FOR SAMPLE 2, THE COBAS E601 PROLACTIN RESULT WAS 847 ULU/ML WHILE THE CENTAUR RESULT WAS 484 ULU/ML. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON ANOTHER CENTAUR ANALYZER WITH A RESULT OF 517 ULU/ML. FOR SAMPLE 3, THE COBAS E601 PROLACTIN RESULT WAS 885 ULU/ML WHILE THE CENTAUR RESULT WAS 617 ULU/ML. THE CUSTOMER SAID THEIR PROLACTIN REFERENCE RANGE FOR NON-PREGNANT FEMALES WAS 102-496 ULU/ML. THE CENTAUR REFERENCE RANGE WAS 59-620 ULU/ML. THE REFERENCE RANGE FOR THE OTHER CENTAUR FROM ANOTHER LABORATORY WAS 59-619 ULU/ML. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E601 SERIAL NUMBER WAS (B)(4). ACCORDING TO THE PROLACTIN LABELING "IN CASE OF IMPLAUSIBLE HIGH PROLACTIN VALUES A PRECIPITATION BY POLYETHYLENE GLYCOL (PEG) IS RECOMMENDED IN ORDER TO ESTIMATE THE AMOUNT OF THE BIOLOGICAL ACTIVE MONOMERIC PROLACTIN." THE CUSTOMER DID NOT PERFORM ANY PEG TREATMENT. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179878 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1