BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP HAV TOTAL (AHAVT) ASSAY

    MDR report key: 6076656 · Received November 3, 2016

    Report

    Report Number
    1219913-2016-00203
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 25, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOL
    PMA / PMN Number
    P040017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULTS COMPARED TO (B)(6) RESULTS WITH A FRESH REAGENT READYPACK IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE TIME OF THE EVENT. SIEMENS IS INVESTIGATING THIS INCIDENT AND HAS REQUESTED THE PATIENT SAMPLES FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00203 ON 11/03/2016 FOR (B)(6) ADVIA CENTAUR CP HAV TOTAL (AHAVT) RESULTS ON TWO PATIENT SAMPLES. ON 01/25/2017 - ADDITIONAL INFORMATION: THE CAUSE FOR THE (B)(6) ADVIA CENTAUR CP HAV TOTAL (AHAVT) RESULTS IS UNKNOWN. THE TWO PATIENT SAMPLES WERE PROVIDED FOR ADDITIONAL TESTING. THESE SAMPLES WERE TESTED WITH THREE LOTS OF ADVIA CENTAUR CP AHAVT REAGENT (LOTS 073181, 073182, AND 073183), AND THE RESULTS WERE (B)(6). THE REAGENT READYPACK IN QUESTION WAS NOT PROVIDED FOR ADDITIONAL TESTING. SIEMENS WAS UNABLE TO CONFIRM THE CUSTOMER'S OBSERVATION OF (B)(6) RESULTS. NO CONCLUSION CAN BE DRAWN THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER AND ON TWO PATIENT SAMPLES. THE (B)(6) RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE PATIENT CLINICAL PICTURES, AND (B)(6) RESULTS WHEN THE SAME SAMPLES WERE TESTED WITH A FRESH REAGENT READYPACK OF THE SAME REAGENT LOT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726080 ADVIA CENTAUR CP HAV TOTAL (AHAVT) ASSAY HEPATITIS A VIRUS (ANTI-HAV) ASSAY, LOL SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 182

    Patients

    Seq Age Sex Outcome Treatment
    1