BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR HIV 1/O/2 ENAHNCED (EHIV) ASSAY

    MDR report key: 3003916 · Received March 14, 2013

    Report

    Report Number
    1219913-2013-00047
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    November 14, 2012
    Report Date
    February 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP050030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR EHIV RESULT IS UNKNOWN. THE PATIENT SAMPLE FROM (B)(6) IS NOT AVAILABLE FOR FURTHER INVESTIGATION AND TESTING. THE PATIENT MAY HAVE (B)(6) SINCE (B)(6). THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "THE ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY IS LIMITED TO THE DETECTION OF ANTIBODIES TO (B)(6) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED, AND ACD)." "IT IS RECOGNIZED THAT CURRENTLY AVAILABLE ASSAYS FOR THE DETECTION OF ANTIBODIES TO (B)(6) MAY NOT DETECT ALL INFECTED INDIVIDUALS. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR CP EHIV RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE SAMPLE WAS DRAWN IN THE EMERGENCY ROOM. THE PATIENT WAS TESTED AGAIN (NEW SAMPLE) WITH THE ADVIA CENTAUR CP EHIV THREE MONTHS LATER AT A SISTER HOSPITAL. THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON THE WESTERN BLOT AND WAS (B)(6). VIRAL LOAD TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). (B)(6) TREATMENT WAS NOT PROVIDED AS A RESULT OF THE (B)(6) RESULT. PATIENT CONDITION FOR THE LAST YEAR: LOW GRADE FEVERS, WEIGHT LOSS, ANEMIA. PATIENT CONDITION 2 MONTHS LATER: BRAIN INFECTION. TCELL COUNT DOWN TO 8%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106946 ADVIA CENTAUR HIV 1/O/2 ENAHNCED (EHIV) ASSAY EHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other