BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP PROLACTIN (PRL)

    MDR report key: 10722393 · Received October 22, 2020

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    Report

    Report Number
    1219913-2020-00445
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 22, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CFT
    UDI-DI
    00630414177267
    PMA / PMN Number
    K904714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, A LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULT ON A MALE PATIENT. NO CLINICAL INFORMATION OR HISTORICAL PRL RESULTS WERE PROVIDED FOR THIS PATIENT. THE SAMPLE RECOVERED 8.15 NG/ML AND 8.73 NG/ML WHEN TESTED NEAT (UNDILUTED) AND 9.50 NG/ML WHEN DILUTED 1:5. FURTHER DILUTIONS PERFORMED WERE 1:40, 1:200, 1:250 AND 1:300. THE PRL VALUES INCREASED AS THE DILUTION FACTORS INCREASED BUT THE RELATIVE LIGHT UNITS (RLUS) DECREASED. THIS IS LIKELY DUE TO THE SAMPLE BEING OVER-DILUTED AND NOT A HOOK EFFECT. THERE IS THE POTENTIAL OF READING BELOW ANALYTICAL SENSITIVITY (ON HIGH DILUTION) AND WHEN MULTIPLIED BY THE DILUTION FACTOR IT COULD CAUSE THE PRL DOSE TO SHOW AN INCREASE. THE LARGE DILUTION FACTORS NEED TO BE USED CAUTIOUSLY. QUALITY CONTROL AND OTHER PATIENT SAMPLES ARE NOT AFFECTED. THIS ISSUE ONLY AFFECTED THIS PATIENT SAMPLE. THE SAMPLE IS NOT AVAILABLE FOR FURTHER INTERNAL INVESTIGATION AND THE PATIENT IS NOT SCHEDULED TO BE REDRAWN. THE CUSTOMER CONTINUES TO REPORT CONTROLS AND PATIENTS ON THE ADVIA CENTAUR PROLACTIN ASSAY. A POTENTIAL PRODUCT ISSUE HAS NOT BEEN IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE ASSAY IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2020-00341 (INITIAL RESULT) AND MDR 1219913-2020-00342 (REPEAT RESULT) WERE FILED FROM THE SAME PATIENT ON TWO DIFFERENT DAYS.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULT WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE PHYSICIAN WAS EXPECTING A HIGHER PROLACTIN RESULT. THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) TESTING OF THE SAMPLE, RESULTING LOW. FURTHER SAMPLE DILUTIONS WERE PERFORMED AND THE PRL RESULTS INCREASED AS THE DILUTION FACTOR INCREASED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ADVIA CENTAUR PROLACTIN (PRL) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186783 ADVIA CENTAUR XP PROLACTIN (PRL) PROLACTIN (PRL) IMMUNOASSAY, CFT SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 184 00630414177267

    Patients

    Seq Age Sex Outcome Treatment
    1