BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HCV ASSAY

    MDR report key: 3056247 · Received April 12, 2013

    Report

    Report Number
    1219913-2013-00071
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE NEGATIVE PATIENT RESULT ON TWO ADVIA CENTAUR SYSTEMS IS UNKNOWN. SIEMENS HAS REQUESTED THE DISCORDANT SAMPLE BE SENT IN FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE LIMITATION SECTION: "A NEGATIVE 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. ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR (B)(6) ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6) SEROLOGICAL MARKERS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2013-00071 ON 04/12/2013 FOR A (B)(6) PATIENT RESULT WHEN COMPARED TO ALTERNATE (B)(6) TEST METHODS. ADDITIONAL CUSTOMER INFORMATION HAS BEEN PROVIDED AS WELL AS A SAMPLE FOR FURTHER INVESTIGATION. 07/31/2013 - ADDITIONAL INFORMATION: FEMALE - BORN (B)(6) 1967. THIS PERSON IN AN OCCASIONAL BLOOD BANK DONOR AND THEIR CLINICAL CARD NOTES THAT THERE ARE NO REPORTED CLINICAL SYMPTOMS OR SUSPECTED (B)(6). ADDITIONAL (B)(6) RESULT INFORMATION: REPEAT TESTING ON TWO DIFFERENT ADVIA CENTAUR SYSTEMS WERE : (B)(6). SIEMENS IN-HOUSE TEST RESULTS: REAGENT LOT: 062234, 062235, 062237; ADVIA CENTAUR (B)(6) RESULT: (B)(6). ALTERNATE METHOD (INNO LIA (B)(6)) RESULT: (B)(6), ALL OTHER BANDS WERE (B)(6). THE INNO LIA INSTRUCTION FOR USE RESULT INTERPRETATION IS (B)(6). NOTE: THE INNO LIA INSTRUCTION FOR USE (IFU) SPECIFICITY FOR BLOOD DONORS AND CLINICAL SAMPLES ARE 94.5% AND 93.7% RESPECTIVELY. CONCLUSION: THE CAUSE FOR THE (B)(6) PATIENT RESULT ON TWO ADVIA CENTAUR SYSTEMS WHEN COMPARED TO (B)(6) RESULTS ON MOST OF THE ALTERNATE (B)(6) TEST METHODS IS UNKNOWN. THE (NUCLEAR ACID TEST (NAT) RESULT WAS CONFIRMED TO BE (B)(6) INDICATING THERE IS NO (B)(6) INFECTION. THE CUSTOMER HAS INDICATED THAT THIS PERSON IN AN OCCASIONAL BLOOD BANK DONOR AND THEIR CLINICAL CARD NOTES THAT THERE ARE NO REPORTED CLINICAL SYMPTOMS OR SUSPECTED (B)(6). NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE WHEN RUN IN DUPLICATE AND THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO OTHER ALTERNATE (B)(6) TEST METHODS. THE CUSTOMER PERFORMED REPEAT (B)(6) TESTING ON ANOTHER ADVIA CENTAUR AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS CONFIRMED (B)(6) WITH WESTERN BLOT TESTING. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159018 ADVIA CENTAUR HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 15278236

    Patients

    Seq Age Sex Outcome Treatment
    1