BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 7663394 · Received July 5, 2018

    Report

    Report Number
    1823260-2018-02195
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WHAT IS THE PURPOSE OF PEG TREATMENT OF THE SAMPLES? THE MAIN PURPOSE OF THE TREATMENT BY POLYETHYLENE GLYCOL (PEG) IS TO ESTIMATE THE AMOUNT OF THE BIOLOGICAL ACTIVE MONOMERIC PROLACTIN IN THE SAMPLE. THE PACKAGE INSERT CONTAINS THE FOLLOWING INFORMATION: LIMITATIONS ¿ INTERFERENCE: "A NUMBER OF PUBLICATIONS REPORT THE PRESENCE OF MACROPROLACTIN IN THE SERUM OF FEMALE PATIENTS WITH VARIOUS ENDOCRINOLOGICAL DISEASES OR DURING PREGNANCY. DIFFERING DEGREES OF DETECTION OF THE SERUM MACROPROLACTINS RELATIVE TO MONOMERIC PROLACTIN (22-23 KDA) BY VARIOUS IMMUNOASSAYS HAVE ALSO BEEN DESCRIBED. THIS COULD LEAD TO A FALSE DIAGNOSIS OF HYPERPROLACTINEMIA DEPENDING ON THE IMMUNOASSAY USED." "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." SAMPLE PRETREATMENT BY POLYETHYLENE GLYCOL (PEG) PRECIPITATION TEST PRINCIPLE "MACROPROLACTIN AND OLIGOMERS CAN BE PRECIPITATED BY USING A 25 % AQUEOUS PEG SOLUTION (RATIO 1+1). AFTER CENTRIFUGATION, THE SUPERNATANT CONTAINING MONOMERIC PROLACTIN IS USED IN THE ELECSYS PROLACTIN II ASSAY IN THE SAME WAY AS A NATIVE SAMPLE. THE DILUTION EFFECT WHICH OCCURS DURING SAMPLE PRETREATMENT AND THE COPRECIPITATION OF MONOMERIC PROLACTIN MUST BE TAKEN INTO CONSIDERATION." WAS THERE ANY INTERFERENCE SUSPECTED AND IF YES, DID THE ROOT CAUSE INVESTIGATION INCLUDE TESTING THE PATIENT SAMPLES FOR INTERFERENCES? OTHER THAN INTERFERENCE BY MACROPROLACTIN NO OTHER INTERFERENCES WERE SUSPECTED.

    Additional Manufacturer Narrative · 0

    PRODUCT PROBLEM WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    THE ABBOTT PROLACTIN RESULT WAS 696.6 UIU/ML, NOT 690.06 UIU/ML AS PREVIOUSLY PROVIDED. A GENERAL REAGENT PROBLEM CAN LIKELY BE EXCLUDED BASED ON THE QC DATA PROVIDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FOR 1 PATIENT SAMPLE TESTED ON COBAS 8000 E 602 MODULE COMPARED TO A ABBOTT I 2000. THE INITIAL PROLACTIN COBAS E602 RESULT WAS 931.1 UIU/ML. THE ABBOTT PROLACTIN RESULT WAS 690.06 UIU/ML. POLYETHYLENE GLYCOL (PEG) TREATMENT WAS PERFORMED ON THE PATIENT SAMPLE AND THE SAMPLE WAS RETESTED ON BOTH THE COBAS E602 AND THE ABBOTT I 2000 AT A 2X DILUTION. THE PEG TREATED COBAS E602 PROLACTIN RESULT WAS 756 UIU/ML. THE PEG TREATED ABBOTT I 2000 RESULT WAS 550.6 UIU/ML. FOR A NON PREGNANT FEMALE THE COBAS E602 REFERENCE RANGE IS 102 - 496 UIU/ML AND THE ABBOTT REFERENCE RANGE IS 5.18 - 26.53 NG/ML (108.8 - 557.1 UIU/ML). THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E602 SERIAL NUMBER WAS (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505043 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA 24861500

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR