BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS PROLACTIN ASSAY

    MDR report key: 8302077 · Received February 4, 2019

    Report

    Report Number
    1823260-2019-00443
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 8, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFT
    PMA / PMN Number
    K964748
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A COBAS 8000 E 602 MODULE (SERIAL NUMBER 1286-07) WITH PROLACTIN REAGENT LOT 293123, RESULTING WITH A VALUE OF 16.9 NG/ML. THE CUSTOMER'S RESULTS COULD BE DUPLICATED. THERE WAS NO REMAINING SAMPLE LEFT FOR FURTHER INVESTIGATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    RESPONSE FROM MANUFACTURER GENERAL COMMENTS: THIS CASE OCCURRED IN JAPAN. THE CUSTOMER RETESTED THE PATIENT SAMPLE ON THE ROCHE ANALYZER AND THE ORIGINAL ROCHE RESULT WAS REPRODUCED. BECAUSE OF THIS, THE CUSTOMER BELIEVED THAT THE DIFFERENCE BETWEEN THE ROCHE RESULTS AND OTHER INSTRUMENT RESULT WAS DUE TO THE METHODS USED. THEY REQUESTED ROCHE TO MEASURE THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS PROVIDED TO ROCHE AND ROCHE RAN THE SAMPLE ON A ROCHE OWNED COBAS INSTRUMENT. THE ROCHE RESULT WAS SIMILAR TO THE CUSTOMER RESULTS. SINCE THE RESULT WAS REPRODUCED IT IS NOT LIKELY THAT THERE WAS AN ISSUE WITH THE CUSTOMERS INSTRUMENT. REQUEST FROM FDA: DID ROCHE INVESTIGATED THE COBAS 8000 INSTRUMENT LOG TO DETERMINE WHETHER THERE WERE ANY OTHER ISSUES (BESIDES THE SAMPLE) THAT COULD HAVE CONTRIBUTED TO THE ERRONEOUS RESULTS? RESPONSE FROM MANUFACTURER: THE RESULTS HAVE BEEN REPRODUCED ON AN INDEPENDENT ROCHE OWNED ANALYZER AND THEREFORE IT IS NOT LIKELY THAT THE INSTRUMENT AT THE HOSPITAL HAD AN ISSUE. THE TWO INSTRUMENTS WOULD HAVE HAD TO BEEN IMPACTED IN EXACTLY THE SAME WAY WHICH IS VERY UNLIKELY. REQUEST FROM FDA: WHAT INVESTIGATION WAS CONDUCTED TO RULE OUT DEVICE ERROR OR PRE-ANALYTICAL ERRORS? RESPONSE FROM MANUFACTURER: THE RESULTS HAVE BEEN REPRODUCED ON AN INDEPENDENT ROCHE OWNED ANALYZER. ALONG WITH INSTRUMENT ISSUES, ONE CAN ALSO EXCLUDE PRE-ANALYTICAL ISSUES WITH VERY HIGH PROBABILITY. THE PRE-ANALYTICAL INFLUENCE WOULD HAVE IMPACTED BOTH THE RESULT AT THE HOSPITAL AND AT THE ROCHE SITE. REQUEST FROM FDA: DID OTHER PATIENT SAMPLES RUN AROUND THE SAME TIME ON THE SAME INSTRUMENT HAVE ERRONEOUS RESULTS? RESPONSE FROM MANUFACTURER: WE ARE NOT AWARE OF ANY OTHER ERRONEOUS RESULTS PRODUCED. REQUEST FROM FDA: WHEN WAS QUALITY CONTROL RUN, AND DID QC PASS? RESPONSE FROM MANUFACTURER: SINCE THE RESULTS HAVE BEEN REPRODUCED ON AN INDEPENDENT ROCHE OWNED ANALYZER, QC ISSUES CAN BE EXCLUDED TOO, AS BOTH INDEPENDENT MEASUREMENTS WOULD HAVE HAD TO BE AFFECTED IN THE SAME WAY BY A POTENTIAL ISSUE WITH QC. RESPONSE FROM MANUFACTURER - GENERAL COMMENTS: IN CASE MORE SAMPLE MATERIAL WOULD HAVE BEEN AVAILABLE, THE NEXT STEP WOULD HAVE BEEN TO CONDUCT A DEDICATED INTERFERENCE ANALYSIS. AS THE REQUIRED SAMPLE IS NOT AVAILABLE, ADDITIONAL INTERFERENCE TESTING COULD NOT BE PERFORMED. THE CUSTOMER CONFIRMED THE ROCHE RESULT AND UNDERSTOOD THAT THE DIFFERENCE WAS DUE TO THE METHODS AND MOST LIKELY DUE TO REACTIVITY WITH MACROPROLACTION WHICH IS KNOWN.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULT FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO AN ARCHITECT ANALYZER. THE INITIAL PROLACTIN RESULT WAS 15.1 NG/ML. THE SAME PATIENT SAMPLE WAS RETESTED ON (B)(6) 2019 WITH A PROLACTIN RESULT OF 15.3 NG/ML. ON (B)(6) 2019 THE SAME PATIENT SAMPLE WAS TESTED ON AN ARCHITECT WITH A PROLACTIN RESULT OF 62.8 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94070 ELECSYS PROLACTIN ASSAY RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) CFT ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR