BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3923675 · Received July 9, 2014

    Report

    Report Number
    1219913-2014-00171
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP050030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    10/13/2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. MULTI LOT TESTING WAS PERFORMED USING (B)(6) LOT #S 103168, 103170, AND 103172. THE SAMPLE WAS POSITIVE ACROSS ALL LOTS. EHIV RESULTS (INDEX VALUE): LOT #: RESULT: 103168; >50.00; 103170; >50.00; 103172; >50.00. THE INITIAL FALSE NEGATIVE RESULT WAS NOT CONFIRMED. THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE ALIGNED THE REAGENT PROBE 01 AS PART OF THE SYSTEM INSPECTION. NO ISSUES WERE IDENTIFIED. THE CAUSE FOR THE (B)(6) RESULT IS UNKNOWN. THE PATIENT SAMPLE HAS BEEN REQUESTED FOR FURTHER INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE IFU STATES IN THE LIMITATIONS SECTION: "THE ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY IS LIMITED TO THE DETECTION OF ANTIBODIES TO HIV-1 AND/OR HIV-2 IN HUMAN SERUM OR PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED). IT IS RECOGNIZED THAT CURRENTLY AVAILABLE ASSAYS FOR THE DETECTION OF ANTIBODIES TO HIV-1 AND/OR HIV-2 MAY NOT DETECT ALL INFECTED INDIVIDUALS. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HIV. HIV ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR EHIV RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE SAME PATIENT SAMPLE WAS TESTED AGAIN ON THE SAME INSTRUMENT THE NEXT DAY AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED AGAIN AND THE RESULT WAS (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR EHIV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400669 ADVIA CENTAUR HIV 1/O/2 ENAHNCED (EHIV) ASSAY EHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 160

    Patients

    Seq Age Sex Outcome Treatment
    1