BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 6695032 · Received July 7, 2017

    Report

    Report Number
    1219913-2017-00149
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 13, 2017
    Report Date
    October 17, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    UDI-DI
    00630414473161
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT COMPARED TO A (B)(6) ALTERNATE (B)(6) TEST METHOD RESULT, AND (B)(6) PATIENT IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HCV. HCV 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 HCV ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HCV SEROLOGICAL MARKERS." ADDITIONAL REAGENT LOT INFORMATION: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4), REAGENT LOT: 062271. EXPIRATION DATE: 10/26/2017. DATE OF MANUFACTURER: 10/26/2016.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00149 ON 07/07/2017 FOR A FALSE NON-REACTIVE ADVIA CENTAUR XP HCV (AHCV) PATIENT RESULT. 09/26/2017 - ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RECEIVED, TESTED BY SIEMENS, AND THE ADVIA CENTAUR HCV RESULTS WERE NON-REACTIVE WHEN TESTED ON HCV REAGENT LOT 062270 AND LOT 062275. THE TESTING OF THE SAMPLE ON THE INNO-LIA HCV TEST, SHOWED A 1+ RESULT FOR C1 AND C2. ACCORDING TO THE INNO-LIA MANUFACTURER'S INSTRUCTION FOR USE (IFU), THIS IS CONSIDERED A REACTIVE RESULT. AS THERE ARE MINIMAL TITERS OF OTHER ANTI-HCV ANTIGEN ANTIBODIES (FAINT C1 AND C2 SIGNAL), IT MAY BE POSSIBLE THAT THERE IS AN ISSUE WITH THE PATIENT SAMPLE. FOR EXAMPLE, THE PATIENT MAY BE CLEARING THE INFECTION OR MAY BE IMMUNO-COMPROMISED. THE CAUSE FOR THE FALSE NON-REACTIVE ADVIA CENTAUR XP HCV (AHCV) PATIENT RESULT IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HCV. HCV 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 HCV ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HCV SEROLOGICAL MARKERS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER, AND CONSIDERED DISCORDANT COMPARED TO A (B)(6) ALTERNATE (B)(6) TEST METHOD RESULT. THE PATIENT IS KNOWN TO BE (B)(6). A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS TESTED THE FOLLOWING DAY AND THE (B)(6) RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON ANOTHER ADVIA CENTAUR SYSTEM, AND ALTERNATE (B)(6) TEST METHOD, AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS TESTED FIVE DAYS LATER FOR (B)(6) ON THE ADVIA CENTAUR XP WITH A DIFFERENT (B)(6) REAGENT LOT AND THE RESULTS WERE (B)(6). THE SAME SAMPLE WAS TESTED ON THE ALTERNATE (B)(6) TEST METHOD AND THE RESULT WAS (B)(6). A (B)(6) RESULT WAS REPORTED TO THE PROVIDED. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476269 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062270 00630414473161

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR