BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1030278 · Received April 15, 2008

    Report

    Report Number
    2517506-2008-00032
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 17, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELELVATED RCRP RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED RCRP RESULT OF 188.3 MG/L WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. A SEQUENTIAL SAMPLE WAS TESTED AND A RESULT OF 92.6 MG/L WAS OBTAINED. THE PT WAS GIVEN A LUMBAR PUNCTURE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED RCRP RESULT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED RCRP RESULT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM RCRP FLEX REAGENT CARTRIDGE JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA BC9017

    Patients

    Seq Age Sex Outcome Treatment
    1