BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3081782 · Received April 29, 2013

    Report

    Report Number
    1226181-2013-00190
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE DISCORDANT LOW TBIL RESULTS WAS UNKNOWN. THE FSE REPLACED THE REAGENT PROBE 2 TRANSDUCER, REAGENT PROBE 1 AND REAGENT PROBE 2 AND ALIGNED THE SAMPLE PROBE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW TOTAL BILIRUBIN (TBIL) RESULTS WERE OBTAINED ON A NEONATAL PATIENT SAMPLE (DRAWN ON THREE SUCCESSIVE DAYS) ON THE DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. CORRECTED RESULTS FROM EACH SAMPLE WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TBIL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185848 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1