BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

    MDR report key: 17546065 · Received August 14, 2023

    Report

    Report Number
    1219913-2023-00166
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 25, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    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

    THE INITIAL MDR 1219913-2023-00166 WAS FILED ON 14-AUG-2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED ONE (1) FALSELY DEPRESSED URINE PATIENT SAMPLE RESULT WAS OBTAINED WITH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP, LOT NUMBER 120243) WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER (S/N: (B)(6)). THE RESULT WAS DEPRESSED COMPARED TO THE ATELLICA CH MICROALBUMIN (UALB_2) RESULT AND A RESULT FROM A ROUTINE URINE TEST METHOD. THE INITIAL UCFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. SIEMENS HAS EVALUATED THE INFORMATION. UCFP IS DESIGNED FOR BROAD DETECTION OF PROTEIN STRUCTURES IN URINE AND CEREBROSPINAL FLUID. ALBUMIN IS IDENTIFIED AS A MAIN PROTEIN METABOLITE PRESENT IN SIMILAR FLUIDS. AS THE MORE SPECIFIC UALB_2 RECOVERY WAS GREATER THAN UCFP, THE CUSTOMER QUESTIONED THE ACCURACY OF THE UCFP RESULT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA SURROUNDING THE PROCESSING OF SID 1501. CALIBRATION WAS WITHIN CONFORMANCE. QUALITY CONTROL RECOVERY WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE FOR BOTH METHODS. SIEMENS REVIEWED THE PHOTOMETRIC DATA SURROUNDING THE PATIENT SAMPLE AND OBSERVED THAT THE MILLIABSORBANCE RECOVERY OF THE PATIENT SAMPLE WAS LESS THAN UCFP CALIBRATOR LEVEL 1 WHICH HAS NO PROTEIN (ASSIGNED CONCENTRATION OF 0 MG/DL). THE MILLIABSORBANCE RECOVERY OF SID 1501 WAS UNIQUELY LOW IN COMPARISON TO ALL OTHER UCFP PATIENT SAMPLES PROCESSED AROUND THE SAME TIME. NO PROCESS ERRORS WERE RAISED AROUND THE PROCESSING OF THE PATIENT SAMPLE. REAGENT ISSUES WERE RULED OUT AS QC REPLICATES RECOVERED WITHIN THE ACCEPTABLE RANGE AND OTHER UCFP SAMPLES MET THE CUSTOMER'S EXPECTATION FOR ACCURACY. THE CUSTOMER CITED NO METHOD CONCERNS WERE PRESENT ON THE INSTRUMENT AT THE TIME OF SAMPLE PROCESSING. NO ROUTINE HARDWARE INTERVENTION WAS PERFORMED IN RESPONSE TO THE OBSERVATION. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE SPECIFIC INTERFERENT. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION WAS NOT POSSIBLE AS SAMPLE IS NOT AVAILABLE. THE CUSTOMER AND SYSTEM ARE OPERATIONAL. IN SECTION H6, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES ARE UPDATED.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED A DEPRESSED ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT THAT WAS CONSIDERED DISCORDANT TO THE ATELLICA CH MICROALBUMIN RESULT AND THE RESULT FROM AN ALTERNATE METHOD. QUALITY CONTROL RECOVERED WITHIN EXPECTED RANGES. THE INTERPRETATION OF RESULTS SECTION OF THE ADVIA CHEMISTRY UCFP 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 HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 0

    ONE (1) FALSELY DEPRESSED URINE PATIENT SAMPLE RESULT WAS OBTAINED WITH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP, LOT NUMBER 120243) WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER (S/N: (B)(6)). THE RESULT WAS DEPRESSED COMPARED TO THE ATELLICA CH MICROALBUMIN (UALB_2) RESULT AND A RESULT FROM A ROUTINE URINE TEST METHOD. THE INITIAL UCFP RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED UCFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53241 ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) BIURET (COLORIMETRIC), TOTAL PROTEIN CEK SIEMENS HEALTHCARE DIAGNOSTICS N/A 120243 00630414279206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown