BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 4233900 · Received November 6, 2014

    Report

    Report Number
    1226181-2014-00570
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT AND INSTRUMENT DATA EVALUATION. AFTER EVALUATION, THE CSE REPLACED THE SAMPLE PROBE AND LEVEL SENSE CABLE. THE CSE PERFORMED PROBE ALIGNMENTS AND CLEANED THE WASH PROBES. THE CAUSE OF THE DISCORDANT HCG RESULT IS UNKNOWN. THE CSE SUCCESSFULLY RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT 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 DISCORDANT HCG RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON AN ALTERNATE SYSTEM, RESULTING HIGHER. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED ON AN ALTERNATE SYSTEM, WHICH ALSO RESULTED HIGHER. THE CORRECTED HCG RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713291 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM DHA SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1