BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 5244686 · Received November 23, 2015

    Report

    Report Number
    1226181-2015-00673
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    October 25, 2015
    Report Date
    October 26, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED THAT EVEN THOUGH THE SAMPLE WAS VISIBLY HEMOLYZED, THE INSTRUMENT DID NOT REPORT HEMOLYSIS, ICTERUS, LIPEMIA (HIL). CCC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE CUSTOMER'S HIL CONFIGURATION WAS TURNED OFF IN THEIR SYSTEM CONFIGURATION. QUALITY CONTROLS HAD BEEN IN RANGE ON THE DAY OF EVENT. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA. THERE WAS NO INDICATION OF REAGENT DELIVERY OR SAMPLE DELIVERY ISSUES. IT WAS ALSO DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED AST AND LDI RESULTS IS UNKNOWN. THE CAUSE OF THE SAMPLE BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED ASPARTATE AMINOTRANSFERASE (AST) AND LACTATE DEHYDROGENASE (LDI) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE CUSTOMER STATED THAT THE SAMPLE WAS VISIBLY HEMOLYZED. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO ADMINISTERED UNKNOWN TREATMENT TO THE PATIENT. A NEW SAMPLE OBTAINED FROM THE PATIENT WAS TESTED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED AST AND LDI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774102 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1