BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1983503 · Received February 10, 2011

    Report

    Report Number
    1226181-2011-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    DHA
    PMA / PMN Number
    K970387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED HCG IS LOW CHROME READINGS DUE TO R1 AND R2 PROBE ALIGNMENT. A SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER ASSOCIATE DIRECTED CUSTOMER TO PERFORM APPROPRIATE MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A POSITIVE RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM HCG FLEX® REAGENT CARTRIDGE DHA SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD RXLMAXRH

    Patients

    Seq Age Sex Outcome Treatment
    1