BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 15225933 · Received August 15, 2022

    Report

    Report Number
    2517506-2022-00221
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 18, 2022
    Report Date
    September 30, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    UDI-DI
    00842768013836
    PMA / PMN Number
    K010313
    Removal / Correction Number
    2517506-05/24/2022-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SIEMENS HEALTHCARE DIAGNOSTICS REPRESENTATIVE FROM THE REAGENT MANUFACTURING TECHNICAL OPERATIONS DEPARTMENT OBSERVED A BIAS IN RESULT RECOVERIES DURING AN INTERNAL STUDY WITH CARDIAC TROPONIN-I (CTNI) LOT BA3088 ON THE DIMENSION® RXL MAX® INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (20-SEP-2022): SIEMENS HEALTHCARE DIAGNOSTICS INC. PREVIOUSLY IMPLEMENTED A FIELD CORRECTION (DC-22-02.A.US) ON MAY 18, 2022, FOR CERTAIN LOTS OF DIMENSION CARDIAC TROPONIN I (LTNI AND CTNI). CTNI LOT BA3088 SHARES THE SAME RAW MATERIAL AS THE LOTS NOTED IN THE INITIAL FIELD CORRECTION AND THE INITIAL MDR WAS FILED FOR LOT BA3088 CONSERVATIVELY BASED UPON AN INTERNAL INVESTIGATION. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED A POSITIVE BIAS WITH LITHIUM HEPARIN PLASMA PATIENT SAMPLES WITH DIMENSION® CARDIAC TROPONIN I CTNI FLEX® REAGENT CARTRIDGE LOT BA3088 ON THE DIMENSION® RXL MAX® INTEGRATED CHEMISTRY SYSTEM. LITHIUM HEPARIN PLASMA PATIENT SAMPLES FROM INDIVIDUALS THAT ARE EXPECTED TO BE BELOW THE 99TH PERCENTILE OF 0.07 NG/ML [0.07 G/L] WERE OBSERVED TO HAVE A POSITIVE BIAS. TROPONIN VALUES AS HIGH AS 0.21 NG/ML [0.21 G/L] HAVE BEEN OBSERVED WITH LITHIUM HEPARIN PLASMA THAT ARE EXPECTED TO BE WITHIN THE 99TH PERCENTILE. SERUM SAMPLES COLLECTED FROM NORMAL, HEALTHY INDIVIDUALS WHOSE RESULTS FALL WITHIN THE REFERENCE INTERVAL OR BELOW THE 99TH PERCENTILE OF 0.07 NG/ML [0.07 G/L] WERE NOT IMPACTED BY THIS ISSUE. URGENT MEDICAL DEVICE CORRECTION DC-22-02.B.US DATED SEPTEMBER 22, 2022 AND URGENT FIELD SAFETY NOTICE DC-22-02.B.OUS DATED SEPTEMBER 2022 WERE SENT TO ALL CUSTOMERS WHO HAD BEEN SHIPPED THE CARDIAC TROPONIN-I (CTNI) LOT BA3088. SIEMENS RECOMMENDED THAT CUSTOMERS USE SERUM PATIENT SAMPLES ONLY WHEN PROCESSING SAMPLES WITH CTNI LOT BA3088. CUSTOMERS WERE INSTRUCTED TO DISCARD CTNI LOT BA3088 IF THEY ARE UNABLE TO USE SERUM PATIENT SAMPLES FOR TESTING. SECTION H6 HAS BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00221 WAS FILED ON 15-AUG-2022.

    Description of Event or Problem · 0

    DURING AN INTERNAL INVESTIGATION, SIEMENS REAGENT MANUFACTURING TECHNICAL OPERATIONS OBSERVED A BIAS IN RESULT RECOVERIES WITH CARDIAC TROPONIN-I (CTNI) LOT BA3088 ON A DIMENSION® RXL MAX® INTEGRATED CHEMISTRY SYSTEM. THE ISSUE WAS IDENTIFIED IN AN INTERNAL STUDY. NO PATIENT RESULTS WERE REPORTED TO PHYSICIANS. THERE HAS BEEN NO REPORTED CUSTOMER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987703 DIMENSION® DIMENSION® CTNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. 10444905 BA3088 00842768013836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown