BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 11375349 · Received February 24, 2021

    Report

    Report Number
    2432235-2021-00057
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    October 30, 2020
    Report Date
    April 7, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414573564
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2021-00057 ON 24-FEB-2021. ADDITIONAL INFORMATION (05-APR-2022): SIEMENS REVIEWED THE INFORMATION PROVIDED REGARDING A FALSE REACTIVE RESULT ON MULTIPLE PATIENTS WITH ADVIA CENTAUR XP TOXOPLASMA IGG (TXOG) LOTS (061259, 061263, AND 265) VERSUS ALTERNATE METHODS/PLATFORMS. THE CUSTOMER'S DATA FROM ADVIA CENTAUR XP WITH SERIAL NUMBER IRL44301403 SHOWED THE CALIBRATION WAS COMPARABLE WITH RELEASE DATA, AND QUALITY CONTROL RECOVERY WAS WITHIN PEER AND INSERT RANGES. SIEMENS PERFORMED A STUDY BY RUNNING ONE-HUNDRED (100) PATIENT SAMPLES IN REPLICATES OF THREE (3) WITH ADVIA CENTAUR XP TOXOPLASMA IGG (TXOG) LOTS 265 AND 267, AND NOTED THAT THERE WERE NO LOT-TO-LOT DIFFERENCES BASED ON THE REVIEW OF RESULTS. SIEMENS PERFORMED FURTHER INVESTIGATION. ONE HUNDRED AND FORTY-FIVE (145) PATIENTS WERE SCREENED WITH REAGENT CENTAUR XP LOTS 265 AND 273, AND PATIENTS SHOWED CONSISTENT (REACTIVE/EQUIVOCAL OR NONREACTIVE/EQUIVOCAL) RESULTS ACROSS LOTS. THE CUSTOMER RETURNED A PATIENT SAMPLE, AND SIEMENS PERFORMED TESTING FOR HUMAN ANTI-MOUSE IGG ANTIBODIES (HAMA) INTERFERENCE. THE SAMPLE RESULTED LOW LEVELS OF HAMA. THE RETURNED PATIENT SAMPLE WAS TESTED WITH ANTI-NUCLEAR ANTIBODIES (ANA) AND ANTI-MITOCHONDRIAL ANTIBODIES (AMA) KIT AND INDICATED AN INTERFERENCE WITH THESE TESTS. SIEMENS CONCLUDED THAT ADVIA CENTAUR XP TOXOPLASMA IGG (TXOG) KIT LOTS PERFORM AS INTENDED AND DID NOT IDENTIFY A PRODUCT PERFORMANCE ISSUE. THE ADVIA CENTAUR XP IS OPERATING AS SPECIFIED AND REQUIRES NO FURTHER EVALUATION. SIEMENS UPDATED SECTION H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS) TO INCLUDE NEW CODES. THE FOLLOWING MDRS WERE FILED FOR THE SAME EVENT: 2432235-2021-00054_S1, 2432235-2021-00055_S1, 2432235-2021-00056_S1, 2432235-2021-00058_S1, 2432235-2021-00059_S1, 2432235-2021-00060_S1, 2432235-2021-00061_S1, AND 2432235-2021-00062_S1.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND INFORMED THAT FALSE POSITIVE TOXOPLASMA G (TOXO G) RESULTS WERE OBSERVED ON FIVE (5) DIFFERENT PATIENTS AND SAMPLES. THE CUSTOMER NOTED THAT SAMPLES WERE STORED AT > + 4°C PRIOR TO THE INITIAL RUN REPEAT TESTING. SIEMENS IS INVESTIGATING THE EVENT. THE FOLLOWING MDRS WERE FILED FOR THE SAME EVENT: 2432235-2021-00054, 2432235-2021-00055, 2432235-2021-00056, 2432235-2021-00058, 2432235-2021-00059, 2432235-2021-00060, 2432235-2021-00061, AND 2432235-2021-00062.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE TOXOPLASMA G (TOXO G) RESULTS ON DIFFERENT SAMPLES FROM A PATIENT ON AN ADVIA CENTAUR XP INSTRUMENT. THE CUSTOMER USED THE SAME SAMPLE TO PERFORM REPEAT TESTING ON AN ALTERNATE PLATFORM AND OBSERVED A RESULT OF ZERO (0). THE CUSTOMER NOTED THAT THE SAMPLE TESTED WITH AN ALTERNATE METHOD IS NEGATIVE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE FALSE POSITIVE TOXOPLASMA G (TOXO G) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267207 ADVIA CENTAUR XP ADVIA CENTAUR XP JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP 00630414573564

    Patients

    Seq Age Sex Outcome Treatment
    1 Female