BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    MDR report key: 15432515 · Received September 15, 2022

    Report

    Report Number
    1219913-2022-00306
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 13, 2022
    Report Date
    November 29, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOK
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2022-00306 WAS INITIALLY FILED ON 2022-09-15. ADDITIONAL INFORMATION, 2022-11-09: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF DEPRESSED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. IMPRECISION WAS OBSERVED FOR SEVERAL SAMPLES WHEN REPEAT TESTING WAS PERFORMED USING DIFFERENT INSTRUMENTS. A LOW BIAS WAS SEEN FOR RESULTS PRODUCED BY ONE INSTRUMENT/REAGENT-PACK COMBINATION, BUT QUALITY CONTROL RESULTS WERE WITHIN RANGE, AND CALIBRATION DID NOT DEMONSTRATE ANY BIAS. THE AFFECTED SAMPLES WERE NO LONGER AVAILABLE FOR ADDITIONAL TESTING. IT IS NOTED THAT THE OBSERVED IMPRECISION AFFECTED LOW-END AFP RESULTS FOR A LIMITED NUMBER OF SAMPLES. SIEMENS CANNOT RULE OUT SAMPLE-SPECIFIC ISSUES AS A CAUSE OF THE IMPRECISION. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND HAS REPORTED NO ADDITIONAL DISCREPANCIES. NO FURTHER INVESTIGATION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE OF THE U.S. REPORTED OBSERVATION OF DEPRESSED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THE IFU STATES 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." SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. PATIENT SAMPLES WERE RE-TESTED ON ANOTHER ATELLICA IM INSTRUMENT DUE TO AN OBSERVED NEGATIVE SHIFT IN MOVING AVERAGE FOR AFP RESULTS. HIGHER RESULTS WERE OBTAINED UPON REPEAT TESTING, AND ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603598 ATELLICA IM ALPHA FETOPROTEIN (AFP) AFP IMMUNOASSAY LOK SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown