BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM INSTRUMENT

    MDR report key: 4120908 · Received September 26, 2014

    Report

    Report Number
    1226181-2014-00480
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER PROVIDED QUALITY CONTROL (QC) DATA, WHICH SHOWED QC WERE WITHIN RANGE AT THE TIME OF THE INCIDENT. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCG RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING ON THE SAME INSTRUMENT. 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 RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER ALSO RAN A SINGLE SAMPLE RAPID TEST FOR HCG WHICH RESULTED POSITIVE FOR PREGNANCY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING, RESULTING POSITIVE. THE SAMPLE WAS THEN REPEATED ON THE SAME INSTRUMENT, ALSO RESULTING POSITIVE. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE 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
    601438 DIMENSION RXL MAX WITH HM INSTRUMENT CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1