BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2517506-2017-00435

    MDR report key: 6510973 · Received April 21, 2017

    Report

    Report Number
    2517506-2017-00435
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 21, 2017
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS WERE WITHIN RANGE, THERE WERE NO INSTRUMENT ERRORS, AND SYSTEM CHECKS PASSED. THE CAUSE OF THE DISCORDANT, FALSELY LOW LDI RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED WHEN REPEATED 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, FALSELY LOW LACTATE DEHYDROGENASE (LDI) 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 SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND ON OTHER DIMENSION INSTRUMENTS TO CONFIRM THE RESULT, WHICH RESULTED HIGHER THAN THE INITIAL RESULT. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW LACTATE DEHYDROGENASE (LDI).

    Patients

    Seq Age Sex Outcome Treatment
    1