BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3093035 · Received May 3, 2013

    Report

    Report Number
    1226181-2013-00203
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DISCOVERED THAT THE TESTS HAD BEEN ADDED TO THE PATIENT SAMPLE AFTER THE OPERATOR HAD PERFOMED A DILUTION FOR A RESULT ABOVE THE ASSAY RANGE, AND THE SAME SAMPLE IDENTIFICATION NUMBER HAD BEEN USED FOR THE SAMPLE BEING RUN NEAT AND FOR THE DILUTED SAMPLE. INSTRUCTIONS FOR PERFOMING DILUTIONS ON THE DIMENSION VISTA 1500 INSTRUMENT STATE THAT A UNIQUE SAMPLE IDENTIFICATION NUMBER MUST BE ASSIGNED TO TO SAMPLES WITH A MANUAL DILUTION FACTOR. IF THE SAME SAMPLE IDENTIFICATION NUMBER AS THE NEAT RESULT IS USED, ANY ADDITIONAL TESTS ADDED TO THE SAMPLE WILL BE ASSIGNED THE DILUTION FACTOR. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED LDI, ALB, ALP, AST, ALTI, DBIL, TBIL, AND TP RESULTS IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED LACTATE DEHYDROGENASE (LDI), ALBUMIN (ALB), ALKALINE PHOSPHATASE (ALP), ASPARTATE AMINOTRANSFERASE (AST), ALANINE TRANSAMINASE (ALTI), DIRECT BILIRUBIN (DBIL), TOTAL BILIRUBIN (TBIL), AND TOTAL PROTEIN (TP) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN RERUN ON AN ALTERNATE INSTRUMENT AND RESULTED LOWER. THE RERUN RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). AT A LATER DATE, IT WAS DISCOVERED THAT THE RERUN RESULTS HAD NOT BEEN REPORTED OUT. THE SAMPLE WAS RERUN AGAIN ON THE ALTERNATE INSTRUMENT FOR ALL TESTS EXCEPT LDI, AND THE RESULTS MATCHED THE PRIOR RERUN RESULTS. THE RERUN RESULTS FROM THE LATER DATE WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LDI, ALB, ALP, AST, ALTI, DBIL, TBIL, AND TP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194053 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1