BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA

    MDR report key: 10206870 · Received June 29, 2020

    Report

    Report Number
    2517506-2020-00193
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 31, 2020
    Report Date
    July 22, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    DKJ
    UDI-DI
    00842768015427
    PMA / PMN Number
    K061655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WAS FILED 29-JUN-2020. ADDITIONAL INFORMATION (29-JUN-2020): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) COMPLETED THE INVESTIGATION OF THE FALSELY ELEVATED SALICYLATE (SAL) EVENT. HSC HAS REVIEWED THE INFORMATION PROVIDED AND THE INSTRUMENT DATA LOGS AND HAS OBSERVED NO PRODUCT NON-CONFORMANCE. THE CUSTOMER PROCESSED TWO SEPARATE TUBES FROM THE SAME SAMPLE DRAW AND REPORTED CONSISTENT RESULTS ON TWO SEPARATE DIMENSION VISTAS LOCATED AT THE CUSTOMER SITE. ALL PATIENT SAMPLES DISPLAYED ICTERUS INTERFERENCE FLAGS. AS PER THE DIMENSION VISTA'S OPERATORS GUIDE, THE ICTERUS ERROR REPORTS THAT THE ESTIMATED AMOUNT OF BILIRUBIN IN THE SAMPLE IS INTERFERING WITH THE TEST RESULTS. BILIRUBIN CONCENTRATIONS AND POTENTIAL BIAS IS INDICATED WITHIN THE SAL ASSAY INSTRUCTIONS FOR USE. THE CAUSE OF THE EVENT WAS SPECIFIC TO THE PATIENT SAMPLES. ALL SAMPLES ASSOCIATED WITH THE EVENT DISPLAYED ELEVATED ICTERUS INTERFERENCE FLAGS WHICH MAY BIAS THE REPORTED SALICYLATE RESULTS. THE CUSTOMER IS OPERATIONAL. NO ADDITIONAL DISCORDANT RESULTS OR ASSAY CONCERNS WERE REPORTED BY THE CUSTOMER. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND QUESTIONED AN ELEVATED SALICYLATE (SAL) PATIENT RESULT THAT WAS OBTAINED ON THE DIMENSION VISTA SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    A DISCORDANT ELEVATED SALICYLATE (SAL) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS PROCESSED ON THE CUSTOMER'S ALTERNATE DIMENSION VISTA SYSTEM AND AN ELEVATED RESULT WAS OBTAINED. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THE PATIENT WAS ADMINISTERED A MEDICATION FOR SALICYLATE POISONING. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED SALICYLATE RESULT OR THE MEDICATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671830 DIMENSION VISTA DIMENSION VISTA® SAL SALICYLATE FLEX® REAGENT CARTRIDGE DKJ SIEMENS HEALTHCARE DIAGNOSTICS INC K5020 19259BD 00842768015427

    Patients

    Seq Age Sex Outcome Treatment
    1