BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 12832318 · Received November 17, 2021

    Report

    Report Number
    2517506-2021-00322
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 25, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (01-DEC-2021): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE. THE CSE OBSERVED THE CUVETTE FILM HEIGHT WAS NOT CORRECT. THIS RESULTED IN IMPROPER CUVETTE MANUFACTURING AND WICKING OF THE REAGENT. THE CSE REPLACED THE CUVETTE FORM ASSEMBLY AND ADJUSTED THE CUVETTE FILM HEIGHT. THE PART REPLACED BY THE CSE WAS PART OF STANDARD TROUBLESHOOTING/MAINTENANCE OF THE INSTRUMENT FOR ISSUES OF THIS NATURE. THERE IS NO EVIDENCE OF A POTENTIAL SYSTEMIC PRODUCT ISSUE. THE CUSTOMER RECALIBRATED THE MAGNESIUM (MG) ASSAY AND THE ACTIONS TAKEN RESOLVED THE ISSUE. THE CUSTOMER IS FULLY OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2021-00322 WAS FILED 17-NOV-2021.

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING A DISCORDANT FALSELY ELEVATED MAGNESIUM (MG) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL W/LM SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 0

    A DISCORDANT FALSELY ELEVATED MAGNESIUM (MG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL W/LM SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY AND A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE PATIENT HAD A MAGNESIUM INFUSION DELAYED DUE TO THE DISCORDANT FALSELY ELEVATED MAGNESIUM RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT MAGNESIUM RESULT OR THE INFUSION DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730214 DIMENSION® DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION® EXL¿ WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown