BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HIV AG/AB COMBO (CHIV) ASSAY

    MDR report key: 12354015 · Received August 23, 2021

    Report

    Report Number
    1219913-2021-00426
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 11, 2021
    Report Date
    October 1, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON AUGUST 23, 2021. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT NONREACTIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE. SEPTEMBER 22, 2021 ADDITIONAL INFORMATION: THE CUSTOMER REQUESTED A NEW SAMPLE FROM THE PATIENT AND SENT THE SAMPLE TO THEIR SUPPORT LABORATORY FOR TESTING. THE WESTERN BLOT RESULT WAS NEGATIVE AND THE ELECTROCHEMILUMINESCENCE RESULT WAS NEGATIVE. THE CUSTOMER AGREED THAT THE ALTERNATE METHOD REACTIVE RESULTS ARE DISCORDANT. THE NEGATIVE RESULT WAS RELEASED TO PATIENT. SIEMENS INVESTIGATED. DISCORDANT NON-REACTIVE RESULTS WERE OBSERVED WITH THE ATELLICA IM CHIV LOT 293. THE SAME SAMPLE RESULTED REACTIVE WITH AN ALTERNATE METHOD. A NEW SAMPLE WAS OBTAINED AND TESTED AT ANOTHER SITE BY THE CUSTOMER. THE NEW SAMPLE WAS TESTED WITH WESTERN BLOT AND ELECTROCHEMILUMINESCENCE METHODS. THE SAMPLE RESULTED NON-REACTIVE WITH BOTH METHODS. THE CUSTOMER NOW IS STATING THE ALTERNATE METHOD RESULTS ARE DISCORDANT AND NOT THE ATELLICA IM CHIV RESULTS. THE CUSTOMER IS REQUESTING NO FURTHER ASSISTANCE WITH THIS ISSUE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT NON-CONFORMANCE IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED. MDR 1219913-2021-00425 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME SAMPLE TESTED ON A DIFFERENT DATE.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION WAS ACCEPTABLE, AND THE QUALITY CONTROL (QC) RESULTS WERE WITHIN THE RANGE. THE SAMPLE WAS CLEAR, AND NO FIBRIN WAS DETECTED. THE SAMPLE WAS REPEATED THREE TIMES AFTER BEING SPUN EACH TIME. THE CUSTOMER SERVICE ENGINEER (CSE) WENT OT THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE ATELLICA IM MAINTENANCE WAS CHECKED, ALL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND UP TO DATE. THE EQUIPMENT ERROR LOGS WERE COLLECTED AND NO ERRORS THAT COULD CONTRIBUTE TO THE PROBLEM WERE IDENTIFIED. THE RESULTS OF THE QUALITY CONTROL WERE EVALUATED AND HAD THE EXPECTED RESULTS FOR THE TEST. THE CALIBRATION OF THE TEST WAS EVALUATED AND NO ERRORS WERE IDENTIFIED THAT WOULD WARRANT A DISCORDANT RESULT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. MDR 1219913-2021-00425 WAS FILED FOR THE SAME SAMPLE TESTED ON A DIFFERENT DATE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED (B)(6) ATELLICA IM (B)(6) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE (B)(6) RESULTS FROM AN ALTERNATE METHOD. THE CUSTOMER DID NOT REPORT THE (B)(6) RESULTS TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249710 ATELLICA IM HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 293

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR