BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HAV TOTAL (AHAVT)

    MDR report key: 3821440 · Received May 20, 2014

    Report

    Report Number
    1219913-2014-00131
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOL
    PMA / PMN Number
    P040017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE CHECKED THE ASPIRATE PROBE WASH AND DISPENSE; CLEANED AND ALIGNED THE REAGENT PROBES; INSPECTED THE SYSTEM; AND CHECKED THE VACUUMS. NO ISSUES WERE IDENTIFIED. THE CAUSE FOR THE DISCORDANT (B)(6) RESULT WITH THE ALTERNATE METHOD IS UNKNOWN. THE MEDICAL HISTORY OF THE PATIENT IS UNAVAILABLE. THE PATIENT SAMPLE HAS BEEN SENT TO ANOTHER LABORATORY FOR GENOTYPE TESTING. THE RESULTS HAVE NOT BEEN RECEIVED YET. THE QUALITY CONTROL (QC) RESULTS WERE WITHIN RANGE AT THE TIME OF TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS MAY DEVELOP HETEROPHILIC ANTIBODIES WHICH MAY CAUSE INTERFERENCE IN IMMUNOASSAYS AND, THUS, ANOMALOUS VALUES MAY BE OBSERVED."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00131 ON MAY 20, 2014. ON 06/03/2014 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS SENT TO THE NATIONAL MICROBIOLOGY LABORATORY FOR HAV GENOTYPING ON THE PCR METHOD. THE GENOTYPING RESULT WAS NEGATIVE. A NEW SAMPLE WAS OBTAINED TO RULE OUT CONTAMINATION. THE PATIENT SAMPLE WAS TESTED AND THE RESULTS WERE THE SAME ((B)(6)). THE PATIENT SAMPLE IS UNAVAILABLE FOR FURTHER INVESTIGATION AT THE MANUFACTURER'S SITE AND THE PATIENT HAS CHECKED OUT OF THE HOSPITAL. BASED ON THE INFORMATION PROVIDED AND PATIENT RESULTS, THE CAUSE APPEARS TO BE AN UNIDENTIFIED SAMPLE SPECIFIC ISSUE, SUCH AS AN INTERFERENT. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP (B)(4) RESULTS WERE OBTAINED FOR TWO SAMPLES FROM THE SAME PATIENT. THE (B)(6) RESULTS WERE (B)(6) WITH THE ADVIA CENTAUR XP AND (B)(6) WITH AN ALTERNATE METHOD. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299428 ADVIA CENTAUR XP HAV TOTAL (AHAVT) HAVT IMMUNOASSAY LOL SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 164

    Patients

    Seq Age Sex Outcome Treatment
    1