BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2478027 · Received March 5, 2012

    Report

    Report Number
    2517506-2012-00038
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JFY
    PMA / PMN Number
    K0703055
    Removal / Correction Number
    2517506-02-22-2013-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED CREATININE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE ORIGINAL MDR (B)(4) 2012. ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) RESULTS WHEN EZCR IS PROCESSED FROM OPEN WELLS THAT ARE IN CLOSE PROXIMITY TO OPEN WELLS OF PHOSPHORUS (PHOS) FLEX REAGENT CARTRIDGES. THE FALSELY DEPRESSED EZCR RESULTS ARE CAUSED BY A EZCR REAGENT INTERACTION WITH THE PHOS REAGENT. AN URGENT MEDICAL DEVICE CORRECTION FOR THE PHOS FLEX REAGENT CARTRIDGE ((B)(4)), (B)(4) WAS ISSUED IN FEBRUARY 2013 TO IMPACTED CUSTOMERS. THE COMMUNICATION PROVIDED REMEDIAL ACTIONS TO CUSTOMERS TO EITHER AVOID THE REAGENT INTERACTIONS OR TO DISCONTINUE THE USE OF EITHER PHOS OR EZCR ON THEIR DIMENSION SYSTEM.

    Description of Event or Problem · 1

    A DISCORDANT LOW (RELATIVE TO ALTERNATE METHODOLOGY) CREATININE RESULT WAS OBTAINED ON A PATIENT SAMPLE. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED BY BOTH METHODOLOGIES AND THE REPEAT RESULTS AGREED WITH AND CONFIRMED THE HIGHER RESULTS OF THE ALTERNATE METHODOLOGY. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED AS A RESULT OF THE FALSELY DEPRESSED CREATININE RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB2124

    Patients

    Seq Age Sex Outcome Treatment
    1