BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP HBSAG ASSAY

    MDR report key: 6118082 · Received November 21, 2016

    Report

    Report Number
    1219913-2016-00224
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 23, 2015
    Report Date
    November 21, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE CSE PERFORMED A CARRYOVER CHECK, AND NO CARRYOVER ISSUE WAS OBSERVED. THE CAUSE FOR THE ADVIA CENTAUR CP INITIALLY (B)(6) PATIENT RESULT, AND A INCREASED NUMBER OF INITIALLY (B)(6) RESULTS OBSERVED BY THE CUSTOMER IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR CP (B)(6) TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING FOR INITIALLY REACTIVE RESULTS < 50: "SAMPLES WITH AN INDEX VALUE OF GREATER THAN OR EQUAL TO 1.00 BUT LESS THAN OR EQUAL TO 50 ARE CONSIDERED (B)(6). IT IS RECOMMENDED THAT THE TEST BE REPEATED IN DUPLICATE. IF TWO OF THE THREE RESULTS ARE (B)(6), THE SAMPLE IS CONSIDERED (B)(6). · IF AT LEAST TWO OF THE THREE RESULTS ARE (B)(6), THE SAMPLE IS REPEATEDLY (B)(6). THE PRESENCE OF (B)(6) SHOULD BE CONFIRMED WITH THE ADVIA CENTAUR CP (B)(6) CONFIRMATORY ASSAY, ADDITIONAL (B)(6) MARKER ASSAYS, OR ANOTHER APPROVED CONFIRMATORY METHOD." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR CP (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT COMPARED TO (B)(6) REPEAT TEST RESULTS. THE CUSTOMER HAS OBSERVED A HIGH NUMBER OF INITIALLY (B)(6) RESULTS. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP (B)(6) ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767155 ADVIA CENTAUR CP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 063185

    Patients

    Seq Age Sex Outcome Treatment
    1