BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY

    MDR report key: 3856155 · Received June 9, 2014

    Report

    Report Number
    1219913-2014-00140
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2014. THE FSE REPLACED THE PINCH VALVE TUBING AND WASH BLOCKS. THE FSE CHECKED THE PROBE DISPENSE AND REPLACED THE MANIFOLD ASSEMBLY. THE CUSTOMER VERIFIED THE QUALITY CONTROL. ON THE FOLLOW-UP VISIT ON (B)(4) 2014, THE FSE REPLACED THE ASPIRATE MANIFOLD ASSEMBLY, THE ACID AND BASE PUMP, AND BLEACH VALVES. THE FSE PRIMED THE ACID AND BASE AND CHECKED THE SYSTEM FOR BLEACH. THE CUSTOMER RECALIBRATED ASSAYS. SOME OF THE ASSAY CALIBRATIONS FAILED. THE ACID AND BASE WERE REPLACED. THE RUBELLA G NEGATIVE QC WAS FINE POST-SERVICE. HOWEVER, ON (B)(4) 2014, THE NEGATIVE QC WAS RESULT WAS 4.2 (RANGE 0 TO 3). THE REAGENT READYPACK WAS NOTED TO HAVE MATERIAL ON THE BOTTOM AFTER MIXING. FRESH QC MATERIAL WAS TESTED ON THE SAME REAGENT READYPACK AND THE RESULT WAS 4.5. PATIENT SAMPLES WERE NOT RUN WHEN THE NEGATIVE QC WAS OUT OF RANGE. A NEW REAGENT READYPACK WAS MIXED AND THE QC WAS RUN. THE NEGATIVE QC RESULT WAS 0.2 (WITHIN RANGE). THE CAUSE FOR QC OUT OF RANGE IS POSSIBLE SUSPECT REAGENT READYPACK. THE CAUSE FOR THE DISCORDANT RUBELLA G PATIENT SAMPLE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE QUALITY CONTROL SECTION: TAKING CORRECTIVE ACTION IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS. TAKE THE FOLLOWING ACTIONS: -VERIFY THAT THE MATERIALS ARE NOT EXPIRED. -VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED. -VERIFY THAT THE ASSAY WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PREVIOUSLY NEGATIVE PATIENT SAMPLE WAS TESTED AS PART OF TROUBLESHOOTING THE NEGATIVE QUALITY CONTROL (QC) OUT OF RANGE. THE REAGENT READYPACK WAS CALIBRATED AND THE QC WAS REPEATED. THE NEGATIVE QC WAS IN RANGE. ROUTINE PATIENT SAMPLES WERE NOT RUN WHILE THE QC WAS OUT OF RANGE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336127 ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY RUBELLA G IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 179

    Patients

    Seq Age Sex Outcome Treatment
    1