BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3760189 · Received April 18, 2014

    Report

    Report Number
    1226181-2014-00215
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT AND INSTRUMENT DATA EVALUATION. AFTER EVALUATION, THE CSE CLEANED THE REAGENT PROBES AND CHECKED THE INTEGRATED MULTISENSOR TECHNOLOGY ALIQUOTER PROBES AND DRAINS. THE CSE INSTRUCTED THE CUSTOMER TO ENSURE SAMPLES ARE NOT INVERTED WHEN BEING TRANSPORTED TO THE INSTRUMENT AND TO FOLLOW THE PROPER PRE-ANALYTICAL SAMPLE HANDLING PROCEDURES AS PER THE TUBE MANUFACTURERS INSTRUCTIONS FOR USE. THE CAUSE OF THE DISCORDANT CALCIUM, POTASSIUM, UREA NITROGEN AND CREATININE RESULTS IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CALCIUM (CA), POTASSIUM (K), UREA NITROGEN (BUN) AND CREATININE (CREA) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE RESULTS OBTAINED FROM THE ALTERNATE INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA, K, BUN AND CREA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237127 DIMENSION VISTA 1500 CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1