BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

    MDR report key: 17509507 · Received August 11, 2023

    Report

    Report Number
    1219913-2023-00164
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 24, 2023
    Report Date
    September 15, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEK
    UDI-DI
    00630414279206
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT AN OBSERVATION OF DISCORDANT LOW ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP), LOT 120243 RESULTS ON A URINE SAMPLE. THE RETEST RESULT ON AN ALTERNATE METHOD WAS HIGHER AND REPORTED AS CORRECT. THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2023-00164 ON 2023-08-11. ADDITIONAL INFORMATION - 2023-08-15 SIEMENS COMPLETED INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVATION OF DISCORDANT LOW ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP), LOT 120243 RESULTS. THE INITIAL ISSUE WAS REPORTED AS INCONSISTENT ATELLICA CH URINARY CEREBROSPINAL FLUID PROTEIN (UCFP) RECOVERY IN COMPARISON TO THIRD-PARTY REAGENT MANUFACTURER'S CEREBROSPINAL AND URINE TOTAL PROTEIN. THE CUSTOMER OBSERVED ATELLICA CH UCFP RECOVERY BELOW THE MEASUREMENT INTERVAL OF 60 MG/L. THE SAME SAMPLE WAS PROCESSED ON A NON-SIEMENS ANALYZER CONFIGURED TO PROCESS THIRD-PARTY REAGENT MANUFACTURER'S CEREBROSPINAL AND URINE TOTAL PROTEIN. THE METHOD RECOVERED A VALUE OF 101 MG/L. SIEMENS HAS REVIEWED THE AVAILABLE INFORMATION AND MADE THE FOLLOWING DETERMINATION. ATELLICA SOLUTION INTERFACE PROVIDES AVAILABLE TEST DETAILS WHICH INCLUDES IN-DEPTH PATIENT INFORMATION. THE TEST DETAILS SCREEN PROVIDES THE CALCULATED CONCENTRATION IN COMPARING THE SAMPLE SIGNAL AGAINST ITS VALID ATELLICA CH UCFP CALIBRATION CURVE. THAT CALCULATED CONCENTRATION IS A NEGATIVE NUMBER WHICH CONCERNS THE CUSTOMER. SAMPLES WHICH RECOVER BELOW THE DEFAULT MEASUREMENT INTERVAL OF 60 MG/L WILL SUPPRESS THE RESULT VALUE AND REPORT A GENERAL <60 MG/L WITH THE RESULT FLAG 'MEASUREMENT INTERVAL'. THE SIGNAL RESPONSE BY THE PATIENT SAMPLES WAS BELOW THE LIMIT OF DETECTION THEREFORE SUPPORTS LITTLE TO NO DETECTION OF PROTEIN WITHIN THE PATIENT SAMPLE. THE LIMIT OF DETECTION IS SET AS THE LOWEST CONCENTRATION OF PROTEIN THAT CAN BE DETECTED AT A PROBABILITY OF 95%. SIEMENS INVESTIGATION INCLUDED AN ASSESSMENT OF REAGENT, INSTRUMENT, AND SAMPLE DATA. CALIBRATION CURVE MET AUTO-ACCEPTANCE AND UCFP QC RECOVERY WAS WITHIN RANGE SUPPORTING THAT THE REAGENT WAS WORKING AS INTENDED. THERE WAS NO INDICATION FROM THE ATELLICA CH UCFP TEST THAT THE RECOVERY WAS INACCURATE OR DID NOT MEET THE CLINICAL PICTURE. NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. NO PROCESS ERRORS WERE REPORTED. NO HARDWARE INTERVENTION WAS COMPLETED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF INCONSISTENT RECOVERY BETWEEN THE METHODS MAY INCLUDE METHOD DETECTION, CLINICAL ANALYZER BIAS, AND/OR SAMPLE INTERFERENTS. SIEMENS REPORTS NO CLAIMS OF CORRELATION BETWEEN SIEMENS HEALTHINEERS UCFP AND THIRD-PARTY REAGENT FOR DETECTION OF TOTAL PROTEIN. THE ATELLICA CH HARDWARE AND SOFTWARE IS ACTING WITHIN EXPECTATION IN CONSIDERATION OF SAMPLE RESULT FLAGGING AND REPORTING OF A NEGATIVE CONCENTRATION. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER INFORMED SIEMENS OF DISCORDANT LOW ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP), LOT 120243 RESULTS ON A URINE SAMPLE. THE RETEST RESULT ON AN ALTERNATE METHOD WAS HIGHER. THE DISCORDANT RESULTS WERE NOT REPORTED. THE SAMPLE WAS RETESTED USING AN ALTERNATE UCFP METHOD AND THE RESULT WAS REPORTED AS CORRECT AND NOT QUESTIONED BY THE PHYSICIAN. QC WERE ALL WITHIN THE NORMAL RANGES. THE PATIENT HAS TYPE 2 DIABETES, MEDICATION IS UNKNOWN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084499 ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) BIURET (COLORIMETRIC), TOTAL PROTEIN CEK SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 120243 00630414279206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown