BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP RUBELLA M (RUB M) ASSAY

    MDR report key: 3829252 · Received May 23, 2014

    Report

    Report Number
    1219913-2014-00129
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LFX
    PMA / PMN Number
    K010668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE NON-REACTIVE RUBELLA M TEST RESULT ON REPEAT TESTING WHEN COMPARED TO THE INITIAL REACTIVE ADVIA CENTAUR XP AND POSITIVE ALTERNATE TEST METHODS RESULT IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE APPROXIMATELY ONE MONTH EARLIER AND PERFORMED A SYSTEM PREVENTATIVE MAINTENANCE. THE QUALITY CONTROL RESULTS WERE REVIEWED AND WERE IN SPECIFICATIONS AT THE TIME OF THIS ISSUE AND THERE NO OTHER KNOWN NON-REACTIVE DISCORDANT RESULTS. THE CUSTOMER RUNS APPROXIMATELY 400 TO 500 ADVIA CENTAUR RUBELLA M SAMPLES PER MONTH. THE CUSTOMER'S APPROXIMATE RUBELLA M ASSAY SENSITIVITY (449/450) IS 99.78% AND MEETS THE INSTRUCTION FOR USE (IFU) SENSITIVITY CLAIM. SIEMENS HAS REQUESTED THE PATIENT'S SAMPLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00129 ON 05/23/2014 FOR AN ADVIA CENTAUR XP RUBELLA M FALSE NEGATIVE PATIENT RESULT AND MDR SUPPLEMENTAL REPORT 1 ON 06/04/2014 FOR OTHER ASSAY TEST RESULT INFORMATION. 06/13/2014 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. SIEMENS INVESTIGATION RESULTS: THE PATIENT SAMPLE WAS TESTED FOR ADVIA CENTAUR XP RUBELLA M WITH TWO REAGENT LOTS AND ALSO RUN ON AN ALTERNATE INSTRUMENT AND RUBELLA M TEST METHOD. THE TEST RESULTS WERE NEGATIVE FOR RUBELLA M ON BOTH TEST METHODS. THE FALSE POSITIVE ADVIA CENTAUR XP RUBELLA M RESULT OBSERVED BY THE CUSTOMER WAS NOT CONFIRMED ON THE PATIENT SAMPLE THAT WAS RECEIVED FOR FURTHER INVESTIGATION. THE CAUSE FOR THE CUSTOMER'S OBSERVED POSITIVE ADVIA CENTAUR XP RUBELLA M RESULT IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. SYSTEM: ADVIA CENTAUR XP, REAGENT LOT: 064160, RESULTS: 0.25 (INDEX) NON-REACTIVE; ADVIA CENTAUR XP, 064161, 0.48 (INDEX) NON-REACTIVE. INTERPRETATION OF RESULTS: <0.8 IS CONSIDERED NON-REACTIVE. ALTERNATE RUBELLA M INSTRUMENT AND TEST METHOD RESULT: REAGENT LOT: 226, RESULT: 0.61 (INDEX) NON-REACTIVE. INTERPRETATION OF RESULTS: <0.9 IS CONSIDERED NON-REACTIVE. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: " IN THE ABSENCE OF CLINICAL SYMPTOMS OR KNOWN EXPOSURE, A DIAGNOSIS OF A PRIMARY RUBELLA INFECTION SHOULD NOT BE BASED ON A POSITIVE RESULT ALONE. THE SPECIMEN SHOULD BE CONFIRMED USING ANOTHER METHOD BEFORE MAKING THE DIAGNOSIS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00129 ON 05/23/2014 FOR AN ADVIA CENTAUR XP RUBELLA M FALSE NEGATIVE PATIENT RESULT. ON 05/13/2014 ADDITIONAL INFORMATION: OTHER ASSAY TEST RESULTS. DATE: 05/05/2014. ASSAY RESULTS. RUBELLA G >500 IU/ML ((B)(4)). TOXO G 86.6 IU/ML ((B)(4)). TOXO M 0.42 INDEX ((B)(4)).

    Description of Event or Problem · 1

    FALSE NEGATIVE ADVIA CENTAUR XP RUBELLA M RESULTS WERE OBTAINED ON A PATIENT SAMPLE WHEN REPEAT TESTING WAS PERFORMED. THE INITIAL RESULT WAS POSITIVE AND THE CUSTOMER'S INTERNAL PROTOCOL IS TO PERFORM REPEAT TESTING ON ALL POSITIVE RESULTS. THE REPEAT RUBELLA M RESULTS WHEN RUN IN DUPLICATE WERE NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE RUBELLA M TEST METHOD AND THE RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE ADVIA CENTAUR XP RUBELLA M RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308467 ADVIA CENTAUR XP RUBELLA M (RUB M) ASSAY RUBELLA M IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 064160

    Patients

    Seq Age Sex Outcome Treatment
    1