BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 8695551 · Received June 13, 2019

    Report

    Report Number
    2517506-2019-00239
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 19, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2019-00239 ON (B)(6) 2019. ADDITIONAL INFORMATION ((B)(6) 2019): SIEMENS COMPLETED THE INVESTIGATION AND CONCLUDED THAT THE ISSUE IS NOT A REAGENT LOT OR METHOD ISSUE. THE CAUSE OF THE EVENT WAS DUE TO THE SAMPLE DELIVERY, AND WAS RESOLVED WITH SAMPLE FLUSH PUMP MAINTENANCE. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SECTION H6: RESULTS AND CONCLUSION CODES ARE UPDATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). CUSTOMER STATED THAT THE QUALITY CONTROLS (QC) WERE WITHIN RANGE. AS PER SIEMENS INSTRUCTIONS, THE CUSTOMER RAN A SERVICE AND SAMPLER ABSORBANCE TEST (SABS) WHICH FAILED. CUSTOMER IDENTIFIED A SCREW THAT CAME OFF THE SAMPLE FLUSH PUMP AND REATTACHED IT. AFTER REATTACHING, THE CUSTOMER REPEATED THE SERVICE AND SABS TEST SUCCESSFULLY. CUSTOMER RERAN QC WITH PASSING RESULTS, STATED SYSTEM WAS OPERATIONAL AND PATIENT SAMPLES WERE BEING PROCESSED SATISFACTORILY. THE CAUSE OF THE DISCORDANT ECO2 RESULT IS UNKNOWN. SIEMENS IS STILL INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INSTRUMENT, RESULTING LOWER AND AS EXPECTED. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT REPORT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ECO2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492014 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1