BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6512194 · Received April 21, 2017

    Report

    Report Number
    2517506-2017-00429
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ECREA RESULTS IS USER ERROR. THE CUSTOMER WANTED TO ADJUST THE DECIMALS ON THE VISTA ASSAYS SO THAT THE RESULTS WOULD BETTER MATCH WITH THE DECIMALS IN THEIR LABORATORY INFORMATION SYSTEM. THE CUSTOMER DID NOT REALIZE THAT FOR THE ECREA ASSAY, THERE IS A SETTING OF "DIGITS OF PRECISION" IN THE METHOD CONFIGURATION IN THE VISTA SYSTEM. FOR ECREA, THE CUSTOMER CHANGED THE "DIGITS OF PRECISION" FROM 4 TO 1 CAUSING THE RESULTS TO BE ROUNDED UP OR DOWN AND THIS CHANGE CAUSED THIS ISSUE. THE ROUNDING CAN CAUSE BOTH ELEVATION AND DEPRESSION OF RESULTS. THIS ERROR TOOK PLACE EARLY IN THE MORNING ON (B)(6) AND THEY DISCOVERED THE MISTAKE AROUND NOON BECAUSE THE QUALITY CONTROL RECOVERIES SHOWED OUT OF RANGE VALUES. NO QC'S HAD BEEN RUN RIGHT IMMEDIATELY AFTER THE CHANGE OF DIGITS OF PRECISION. AFTER RECOGNIZING THEIR ERROR, THE CUSTOMER RESOLVED THE ISSUE BY CHANGING THE "DIGITS OF PRECISION" BACK TO THE CORRECT NUMBER VALUE. SAMPLES RUN DURING THE SHORT INTERVAL WITH THE INCORRECT DIGITS OF PRECISION IN PLACE WERE EVALUATED BY THE CUSTOMER. RESULTS WERE REGENERATED FROM INSTRUMENT DATA AND CORRECT VALUES OBTAINED. THE CUSTOMER STATED THAT THE LAB DOCTOR LOOKED AT ALL THE RESULTS OBTAINED DURING THE INTERVAL AND DECIDED WHICH RESULTS NEEDED TO BE CORRECTED. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. .

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON PATIENT SERUM SAMPLES FOR ENZYMATIC CREATININE (ECREA) ON THE DIMENSION VISTA 1500 INTERNATIONAL SYSTEM. PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). AFTER AN ERROR IN ENTERING INCORRECT DIGITS OF PRECISION VALUE IN THE METHOD CONFIGURATION FOR ECREA WAS DISCOVERED BY THE CUSTOMER UPON RUNNING QUALITY CONTROL, THE DIGITS OF PRECISION VALUES WERE CORRECTED. RESULTS WERE RECALCULATED FROM THE ORIGINAL INSTRUMENT RUN DATA AND CORRECTED RESULTS WERE ISSUED FOR SOME SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECREA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292687 DIMENSION VISTA® DIMENSION VISTA® 1500 INTERNATIONAL SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA 1500 INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1