BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3241292 · Received July 22, 2013

    Report

    Report Number
    1226181-2013-00333
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHA
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) AFTER OBTAINING TWO HI A ERRORS ON ONE PATIENT SAMPLE. AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DISCOVERED THAT THE AUTODILUTE VOLUME WAS NOT ENTERED FOR THE HCG METHOD, PREVENTING THE SAMPLE FROM BEING DILUTED AND RERUN. THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO ENTER THE AUTODILUTE VOLUME INTO THE METHOD PARAMETERS AND RERUN THE PATIENT SAMPLE, WHICH THE CUSTOMER DID. THE PATIENT SAMPLE RESULTED AS EXPECTED UPON AUTODILUTION BY THE INSTRUMENT. THE TSC SPECIALIST ALSO ADVISED THE CUSTOMER TO CONTACT THEIR LIS VENDOR TO MODIFY THE INTERFACE SO THAT RESULTS WITH ERROR MESSAGES WOULD NOT BE REPORTED. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCG RESULT WAS A CONFIGURATION ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS FLAGGED BY THE INSTRUMENT WITH A HI A ERROR, INDICATING THAT THE SAMPLE REQUIRED DILUTION. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED WITH A HI A ERROR AGAIN. THE OPERATOR THEN SET THE AUTODILUTE VOLUME FOR HCG ON THE INSTRUMENT TO DILUTE THE SAMPLE, WHICH WAS RERUN AND RESULTED AS EXPECTED. IT IS UNKNOWN IF THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340290 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER DHA SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1