BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2432235-2017-00544

    MDR report key: 6914484 · Received October 4, 2017

    Report

    Report Number
    2432235-2017-00544
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 5, 2017
    Report Date
    October 30, 2017
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND STATED THAT THE ERROR RESULT OBTAINED ON THE DAY OF THE ISSUE COULD NOT BE LOCATED. QUALITY CONTROLS BEFORE AND AFTER RUNNING AFFECTED PATIENT SAMPLE WAS WITHIN ACCEPTABLE RANGE. DUE TO THE LOW VOLUME AVAILABLE THE SAMPLE WAS POURED OFF INTO A SMALL SAMPLE CONTAINER CUP WHICH WAS INSERTED TO THE ORIGINAL TUBE FOR ANALYSIS ON THE SYSTEM. ALL FOUR RESULTS FOR TBIL_2 WERE ANALYZED IN THE SIMILAR MANNER. THE CUSTOMER INSPECTED THE SAMPLE VISUALLY AFTER THE FIRST RESULT WITH K FLAG, WHICH WAS FOUND TO BE FREE OF FIBRIN, HEMOLYSIS AND BUBBLES. THE CUSTOMER DID NOT RUN SERUM INDICES TEST ON THE SYSTEM. THE SAMPLE WAS FRONT LOADED ON THE SAMPLE TURNTABLE OF THE SYSTEM. THE CUSTOMER WAS ADVISED TO CHECK THE SAMPLE TUBES AND CUPS FOR SUFFICIENT SAMPLE VOLUME AND REAGENT CONTAINER FOR FOAM OR BUBBLES. QUALITY CONTROLS WERE ACCEPTABLE FOR OTHER ASSAYS. THE CUSTOMER IS MONITORING THE PERFORMANCE OF TBIL_2. THERE ARE NO REPORTS OF ADDITIONAL DISCORDANT RESULTS. THE CAUSE OF THE DISCORDANT, FALSELY LOW TBIL_2 RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2017-00544 WAS FILED ON OCTOBER 4, 2017. ADDITIONAL INFORMATION (10/06/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA PROVIDED AND STATED THAT THERE WAS NO REAGENT OR METHOD ISSUE. THE HSC SPECIALIST ALSO STATED THAT THE SAMPLE BEING POURED OFF INTO A SAMPLE CUP IS CONSISTENT WITH POOR ASPIRATION DUE TO BUBBLES OR FOAM IN THE SAMPLE OR POSSIBLE ALIGNMENT OF THE PROBE TO THE SAMPLE CUP. THE ISSUE WAS ISOLATED TO ONE SAMPLE. THE ADVIA CHEMISTRY XPT TOTAL BILIRUBIN_2 (TBIL_2) INSTRUCTIONS FOR USE INDICATE ENSURING SAMPLES ARE FREE OF BUBBLES, FIBRIN PRIOR TO ANALYSIS. THE CUSTOMER IS BEING MORE VIGILANT OF THE SAMPLE INTEGRITY PRIOR TO ANALYSIS AND HAS NOT HAD ANOTHER OCCURRENCE. THE CAUSE OF THE DISCORDANT, FALSELY LOW TBIL_2 RESULT ON ONE PATIENT SAMPLE IS UNKNOWN.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW TOTAL BILIRUBIN_2 (TBIL_2) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE UPON AUTOMATIC REPEAT TESTING ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE SAMPLE WAS INITIALLY RUN ON THE SAME INSTRUMENT, RESULTING AS AN ERROR WITH A K FLAG, INDICATING THAT THE MAXIMUM ABSORBANCE LIMIT WAS EXCEEDED. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT, RESULTING HIGHER BOTH TIMES. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW TBIL_2 RESULT.

    Patients

    Seq Age Sex Outcome Treatment
    1