BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 5370797 · Received January 15, 2016

    Report

    Report Number
    1226181-2016-00023
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 23, 2015
    Report Date
    December 23, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE DISCOVERED THAT TWO URINE QUALITY CONTROL (QC) SAMPLES WERE ASPIRATED PRIOR TO ASPIRATION OF SAMPLE (B)(6). THE CSE REPLACED THE ALIQUOT PROBE AND DRAIN AND RAN QC AND A QUICK CHECK, WHICH WERE ACCEPTABLE. THE CSE ALSO RAN ALTERNATING URINE AND SERUM SAMPLES WITHOUT ANY ISSUES. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA AND DETERMINED THAT THERE WAS NO ALIQUOTTER MALFUNCTION BASED ON THE ERROR LOGS. THE HSC SPECIALIST DETERMINED THAT THE CAUSE OF THE DISCORDANT CA, K, ALTI, CO2, GLU, TP, NA, BUN AND CREA RESULTS ON TWO PATIENT SAMPLES WAS RELATED TO SAMPLE SPECIFIC ISSUES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES TESTED ON A DIMENSION VISTA 1500 INSTRUMENT. SAMPLE ID (B)(6) HAD DISCORDANT RESULTS FOR CALCIUM (CA), POTASSIUM (K), ALANINE AMINOTRANSFERASE (ALTI), CARBON DIOXIDE (CO2), GLUCOSE (GLU), AND TOTAL PROTEIN (TP). SAMPLE ID (B)(6) HAD DISCORDANT RESULTS FOR SODIUM (NA), UREA NITROGEN (BUN), CREATININE (CREA), K, CA, AND CO2. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE PHYSICIAN(S) SENT THE PATIENTS TO AN EMERGENCY ROOM DUE TO THE DISCORDANT RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING DIFFERENT FROM THE INITIAL RESULTS. THE CORRECTED RESULTS FROM THE ALTERNATE DIMENSION VISTA INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA, K, ALTI, CO2, GLU, TP, NA, BUN AND CREA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29464 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1