BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3655818 · Received March 3, 2014

    Report

    Report Number
    1219913-2014-00054
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP050030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00054 ON MARCH 3, 2014. SIEMENS FILED THE MDR 1219913-2014-00054 SUPPLEMENTAL REPORT 1 ON APRIL 18, 2014. 04/28/2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT TWO PATIENT SAMPLES TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. MULTI LOT TESTING ON TWO LOTS OF THE ADVIA CENTAUR (B)(4) WAS PERFORMED ON THE PATIENT SAMPLES. THE LOT NUMBERS WERE 103127 AND 103131. THE RESULTS WERE (B)(6) ACROSS THE LOTS. THIS IS THE SAME OBSERVATION AS THE CUSTOMER. (B)(6). THE PATIENT SAMPLES WERE ALSO TESTED IN A CONDITION WHERE THE ASSAY IS SPECIFICALLY TESTED FOR THE (B)(6). IN THE SEPARATE ANTIGEN TESTING, THE PATIENT SAMPLES INDICATED A STRONG SPECIFIC (B)(6) TO THE P24 WETCAKE PORTION OF THE (B)(4) ASSAY. THE SAMPLES COULD NOT BE TESTED WITH THE REST OF THE (B)(6) PORTIONS OR WITH THE (B)(4) ASSAY DUE TO QUANTITY NOT SUFFICIENT. FURTHER INVESTIGATION COULD NOT BE PERFORMED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00054 ON MARCH 3, 2014. ON 03/28/2014 ADDITIONAL INFORMATION: THE SIEMENS FIELD APPLICATION SPECIALIST (FAS) EXPLAINED TO THE CUSTOMER THE DIFFERENCES BETWEEN THE EHIV AND CHIV ASSAYS. THE CHIV ASSAY IDENTIFIES P24 ANTIGEN IN THE EARLY STAGES OF INFECTION AND EHIV DOES NOT. THEREFORE, A PATIENT SAMPLE MAYBE (B)(6) WITH THE EHIV ASSAY AND (B)(6) WITH THE CHIV ASSAY. THE PATIENT SAMPLE WAS REQUESTED FOR FURTHER EVALUATION AT THE MANUFACTURING SITE. PATIENT INFORMATION PROVIDED BY THE CUSTOMER: (B)(6). MALE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR (B)(6) RESULT IS UNKNOWN. A SIEMENS FIELD APPLICATION SPECIALIST (FAS) TO BE SENT TO THE CUSTOMER SITE FOR FURTHER INVESTIGATION. THE IFU STATES IN THE LIMITATIONS SECTION: "THE ADVIA CENTAUR (B)(6) 1/O/2 ENHANCED ASSAY IS LIMITED TO THE DETECTION OF ANTIBODIES TO (B)(6) IN HUMAN SERUM OR PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED). IT IS RECOGNIZED THAT CURRENTLY AVAILABLE ASSAYS FOR THE DETECTION OF ANTIBODIES TO (B)(6) MAY NOT DETECT ALL INFECTED INDIVIDUALS. A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). 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 (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S CLINICAL EVALUATION. THE PATIENT SAMPLE WAS TESTED ON THE (B)(6) ASSAY AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD 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 DISCORDANT ADVIA CENTAUR (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127277 ADVIA CENTAUR HIV 1/O/2 ENAHNCED (EHIV) ASSAY EHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1