BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HCV (AHCV) ASSAY

    MDR report key: 3665152 · Received March 6, 2014

    Report

    Report Number
    1219913-2014-00059
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULT COMPARED THE PATIENT'S (B)(6) TEST HISTORY AND A (B)(6) RESULT FROM ANOTHER LABORATORY IS UNKNOWN. THE (B)(6) QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS AT THE TIME OF THE EVENT. THE CUSTOMER SENT (10) (B)(6) PATIENT SAMPLES AND (10) (B)(6) PATIENT SAMPLES TO ANOTHER LABORATORY WITH AN ALTERNATE (B)(6) TEST METHOD FOR VERIFICATION TESTING AND THE TEST RESULTS WERE 100% IN AGREEMENT. THE CUSTOMER IS INVESTIGATING PATIENT SAMPLE COLLECTION AND PREPARATION. SIEMENS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE IFU STATES IN THE LIMITATIONS SECTION: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO (B)(6)."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00059 ON 03/06/2014 FOR A (B)(6) PATIENT RESULT. (B)(6) 2014 - THE PATIENT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. SIEMENS INVESTIGATION RESULTS: THE TEST RESULTS WERE (B)(6) ON THREE (B)( 6)REAGENT LOTS. THIS IS THE SAME OBSERVATION BY THE CUSTOMER WHOSE TEST RESULTS WERE (B)(6) WITH (B)(6) REAGENT LOT: 062243 (B)(6). THE INNO-LIA (B)(6) SCORE WESTERN BLOT RESULTED IN AN INDETERMINATE RESULT (HAVING A 1+ BAND AT NS3 AND ALL OTHER BANDS (B)(6)). BASED ON SIEMENS INTERNAL TEST RESULTS, THIS IS NOT CONSIDERED A SITE ISSUE OR LOT SPECIFIC ISSUE. THE CAUSE FOR THE (B)(6) ADVIA CENTAUR XP (B)(6) PATIENT RESULT IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. ADVIA CENTAUR REGENT LOT # : 062240, HCV RESULTS: (B)(6); 062243, (B)(6); 062245, (B)(6). INNO-LIA (B)(6) WESTERN BLOT RESULT: INDETERMINATE (1+ BAND AT NS3 AND ALL OTHER BANDS (B)(6)) THE IFU STATES IN THE LIMITATIONS SECTION: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO HEPATITIS C VIRUS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO THE PATIENT'S (B)(6) TEST HISTORY AND A (B)(6) RESULT FROM ANOTHER TESTING LABORATORY. THE CUSTOMER PERFORMED REPEAT (B)(6) TESTING IN DUPLICATE AND THE (B)(6) RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY FOR REPEAT (B)(6) TESTING AND THE RESULT WAS (B)(6). THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135275 ADVIA CENTAUR HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY, MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062243

    Patients

    Seq Age Sex Outcome Treatment
    1