BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2954927 · Received February 11, 2013

    Report

    Report Number
    2517506-2013-00035
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JFY
    PMA / PMN Number
    K073055
    Removal / Correction Number
    2517506-02-22-2013-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) RESULTS WHEN EZCR IS PROCESSED FROM OPEN WELLS OF ENZYMATIC CREATININE (EZCR) FLEX REAGENT CARTRIDGES 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 (B)(4) 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CREATININE RESULTS IS UNKNOWN. THE REAGENT ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSELY DEPRESSED CREATININE RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. AFTER A TREND LOW WAS NOTED BY THE LABORATORY, THE SAMPLES WERE REPEATED WITH A NEW REAGENT SEGMENT (WELL) AND HIGHER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED AS A RESULT OF THE FALSELY DEPRESSED CREATININE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58769 DIMENSION® CLINICAL CHEMISTRY SYSTEM ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DA3229

    Patients

    Seq Age Sex Outcome Treatment
    1