BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP ANTI-TG (ATG) ASSAY

    MDR report key: 7620572 · Received June 20, 2018

    Report

    Report Number
    1219913-2018-00176
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 3, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JZO
    UDI-DI
    00630414579221
    PMA / PMN Number
    K012777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR ON 06/20/2018 FOR A FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) PATIENT RESULT WHEN TESTED WITH REAGENT LOT 085298. 06/27/2018 - ADDITIONAL INFORMATION: THE CAUSE FOR THE FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) PATIENT RESULT WHEN TESTED WITH REAGENT LOT 085298 IS UNKNOWN, AND MAY BE ATTRIBUTED TO SAMPLE PREPARATION AND SAMPLE HANDLING. THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) RESULT IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL (QC) WAS WITHIN ACCEPTABLE RANGES. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN TESTED WITH REAGENT LOT 085298. THE LOW ATG RESULT WAS CONSIDERED DISCORDANT COMPARED TO AN INITIAL POSITIVE RESULT WITH REAGENT LOT 085295. THE INITIAL POSITIVE RESULT WAS IN AGREEMENT WITH THE CLINICAL PICTURE OF THE PATIENT, AND THE RESULT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP ATG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465607 ADVIA CENTAUR XP ANTI-TG (ATG) ASSAY ANTI-TG (ATG) IMMUNOASSAY JZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 085298 00630414579221

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR