BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1148608 · Received August 29, 2008

    Report

    Report Number
    2517506-2008-00083
    Event Type
    Other
    Date Received
    August 29, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CIG
    PMA / PMN Number
    K861700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TOTAL BILIRUBIN RESULT WAS SAMPLE INTEGRITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT WAS OBTAINED ON A NEWBORN PATIENT'S SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND AN ELEVATED RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED AS A RESULT OF THE INCIDENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED TOTAL BILIRUBIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM TBIL FLEX REAGENT CARTRIDGE CIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA BC9113

    Patients

    Seq Age Sex Outcome Treatment
    1