BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CHEMISTRY SYSTEM

    MDR report key: 2389311 · Received December 27, 2011

    Report

    Report Number
    2517506-2011-00184
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Date of Event
    November 29, 2011
    Report Date
    December 2, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JFJ
    PMA / PMN Number
    K061655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 URINE AMYLASE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CHEMISTRY SYSTEM AMYLASE FLEX® REAGENT CARTRIDGE JFJ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 11130BC

    Patients

    Seq Age Sex Outcome Treatment
    1