BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HIV AG/AB COMBO (CHIV)

    MDR report key: 22478792 · Received July 11, 2025

    Report

    Report Number
    1219913-2025-00139
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    May 24, 2025
    Report Date
    September 19, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    UDI-DI
    00630414598543
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER (RSC) AND REPORTED OBSERVATION OF NONREACTIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE, WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. SIEMENS IS EVALUATING THE ISSUE. NOTE: THE OBSERVATION WAS REPORTED IN ASSOCIATION WITH A PRODUCT WHICH IS DISTRIBUTED ONLY OUTSIDE OF THE UNITED STATES. THE REPORTED PMA NUMBER IS ASSOCIATED WITH A US FORM OF THE PRODUCT (SIMILAR PRODUCT).

    Additional Manufacturer Narrative · 0

    MDR 1219913-2025-00139 WAS INITIALLY FILED ON 11-JUL-2025. ADDITIONAL INFORMATION (27-AUG-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED OBSERVATION OF NONREACTIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE, WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. REAGENT ISSUES WERE RULED OUT BASED ON THE REVIEW OF QUALITY CONTROL (QC), WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. THE PATIENT WAS NOT KNOWN TO BE ON ANTI-RETROVIRAL THERAPY. SIEMENS REVIEWED THE PATIENT'S MEDICATION LIST, AND THERE WAS NO KNOWN INTERFERENCE FROM THE SUBSTANCES. THE AFFECTED SAMPLES WERE NOT RETURNED TO SIEMENS FOR FURTHER EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULTS CANNOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF NON-REACTIVE (NEGATIVE) ATELLICA IM HIV AG/AB COMBO (CHIV) RESULTS FOR A PATIENT SAMPLE, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON ALTERNATE METHOD. THE CUSTOMER IDENTIFIED RESULT DISCORDANCE FOR A MALE PATIENT WHO INITIALLY PRODUCED REACTIVE (POSITIVE) CHIV RESULTS. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER, AND THE SAME REACTIVE RESULT WAS OBTAINED. THE SAMPLE WAS SENT TO AN ALTERNATE FACILITY (PUBLIC HEALTH INSTITUTE (ISP) OF CHILE), WHERE THE REACTIVE RESULTS WERE CONFIRMED WITH MOLECULAR TESTING. THIS INITIAL (REACTIVE) RESULT WAS NOT REPORTED TO THE PHYSICIAN. A NEW SAMPLE WAS REDRAWN FROM THE SAME PATIENT AND TESTED ON THE ORIGINAL AND ALTERNATE ATELLICA IM ANALYZERS, AND NON-REACTIVE (NEGATIVE) RESULTS WERE OBTAINED. THESE NON REACTIVE RESULTS WERE CONSIDERED DISCORDANT. THE CUSTOMER TESTED THE SAMPLE AGAIN ON THE ALTERNATE FACILITY (PUBLIC HEALTH INSTITUTE (ISP)), AND THE MOLECULAR TEST RESULT WAS REACTIVE (POSITIVE). THE CUSTOMER REPORTED THE REACTIVE RESULT FROM THE ALTERNATE FACILITY AS CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838670 ATELLICA IM HIV AG/AB COMBO (CHIV) ATELLICA IM HIV AG/AB COMBO (CHIV) MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 87992370 00630414598543

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male