BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    MDR report key: 21068637 · Received January 3, 2025

    Report

    Report Number
    1219913-2025-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 7, 2024
    Report Date
    February 28, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOK
    UDI-DI
    00630414597713
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF ELEVATED ATELLICA IM ALPHA-FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. QUALITY CONTROL (QC) RECOVERED WITHIN LABORATORY ESTABLISHED RANGES. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS EVALUATING THE EVENT.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2025-00002 WAS INITIALLY FILED ON 03-JAN-2025. ADDITIONAL INFORMATION (05-FEB-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF ELEVATED ATELLICA IM ALPHA-FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. IT WAS NOTED THAT THE AFP REAGENT PACKS IN THE CUSTOMER INVENTORY HAD UNDISSOLVED PARTICLES AFTER MIXING THE REAGENT PACKS. HOWEVER, THE 3 LEVELS OF QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN THE LABORATORY TARGET RANGES FOR THE AFFECTED REAGENT PACKS WITH UNDISSOLVED PARTICLES. PER SIEMENS LABELING AND DOCUMENTATION, REAGENT PACKS MUST BE INSPECTED FOR CLUMPING PRIOR TO USE. IF CLUMPING OR UNDISSOLVED PARTICLES ARE OBSERVED, THESE REAGENT PACKS CANNOT BE USED FOR SAMPLE PROCESSING. BASED ON THE AVAILABLE INFORMATION, THE DISCORDANT RESULTS ARE ATTRIBUTED TO THE CUSTOMER'S FAILURE TO FOLLOW THE PROVIDED INSTRUCTIONS. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. CUSTOMER IS OPERATIONAL; NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM ALPHA-FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING KIT LOT 283. ELEVATED RESULTS WERE OBTAINED FOR SEVENTEEN (17) PATIENT SAMPLES. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE RETESTED ON THE ORIGINAL INSTRUMENT AND OBTAINED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457623 ATELLICA IM ALPHA FETOPROTEIN (AFP) ATELLICA IM ALPHA FETOPROTEIN (AFP) LOK SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 64681283 00630414597713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown