BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

    MDR report key: 16523611 · Received March 10, 2023

    Report

    Report Number
    1219913-2023-00048
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 21, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 1219913-2023-00048 WAS FILED ON MARCH 10, 2023. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE SAMPLE RESULTS USING LOT 120243 ON AN ATELLICA CH ANALYZER THAT DID NOT MATCH WITH THE PROFILE OF THE OTHER TESTS PERFORMED ON THIS PATIENT. ADDITIONAL INFORMATION - MARCH 21, 2023: SIEMENS REQUESTED ADDITIONAL INFORMATION REGARDING TRUE RESULTS, PATIENT DIAGNOSIS AND MEDICATIONS AND THIS INFORMATION WAS NOT ABLE TO BE PROVIDED. IN ADDITION, ANOTHER SAMPLE WAS DRAWN, BUT UCFP WAS NOT RUN ON THIS SAMPLE. THE LOWER END OF THE ANALYTICAL MEASURING RANGE FOR UCFP IS 60 MG/L AND THE XUALB IS RUNNING LESS THAN 60 WITH VALUES OF 50, 54 AND 50 MG/L. THIS DOES NOT INDICATE THAT THE TOTAL PROTEIN CONCENTRATION CANNOT STILL BE LESS THAN 60 MG/L. DEPENDING ON THE PATIENT DIAGNOSIS, ALBUMIN CAN MAKEUP A LARGE PORTION OF THE URINE PROTEIN. THE INITIAL ISSUE WAS REPORTED AS LOW URINE PROTEIN. SIEMENS CANNOT DEFINITIVELY DETERMINE THE CAUSE OF THIS DISCREPANT RESULT, OR IF THE RESULT IS INDEED DISCORDANT AT ALL SINCE REQUESTED INFORMATION WAS NOT AVAILABE. CONTRIBUTING FACTORS SUCH AS SAMPLE INTEGRITY, SAMPLE SPECIFIC INTERFERENT AND PREANALYTICAL VARIABLES CANNOT BE RULED OUT. QUALITY CONTROL WAS IN RANGE AND NO ISSUES WERE NOTED WITH OTHER PATIENT SAMPLES INDICATING THAT THE INSTRUMENT AND REAGENTS WERE PERFORMING ACCEPTABLY. REPEAT OF THE SAME SAMPLE WAS NOT PERFORMED AND THE SAMPLE IS UNAVAILABLE. BASED ON THE RESULTS OF THE INVESTIGATION, RETURN OF THE PATIENT SAMPLE IS NOT WARRANTED. A POTENTIAL PRODUCT ISSUE HAS NOT BEEN IDENTIFIED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE SAMPLE RESULTS USING LOT 120243 ON AN ATELLICA CH ANALYZER THAT DID NOT MATCH WITH THE PROFILE OF THE OTHER TESTS PERFORMED ON THIS PATIENT. QUALITY CONTROLS (QC) WERE IN RANGE AT THE TIME OF THE EVENT. 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." THE LIMITATIONS SECTION OF THE IFU STATES: "AS WITH ANY CHEMICAL REACTION, YOU MUST BE ALERT TO THE POSSIBLE EFFECT OF UNKNOWN INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES. THE LABORATORY AND PHYSICIAN MUST EVALUATE ALL PATIENT RESULTS IN LIGHT OF THE TOTAL CLINICAL STATUS OF THE PATIENT." SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE SAMPLE RESULT USING LOT 120243 ON AN ATELLICA CH ANALYZER THAT DID NOT MATCH WITH THE PROFILE OF THE OTHER TESTS PERFORMED ON THIS PATIENT. A RETEST WAS PERFORMED ON THE SAME SAMPLE AND ANALYZER AND THE RESULT WAS SIMILAR TO THE INITIAL RESULT. THE ATELLICA CH UCFP RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS ALSO PROCESSED ON ATELLICA CH ANALYZERS WITH OPEN CHANNEL NON-SIEMENS URINE TOTAL PROTEIN REAGENT. THE CUSTOMER CONSIDERED THESE RESULTS TO BE FALSELY DEPRESSED AS WELL. RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT UCFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182187 ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) TOTAL PROTEIN CLINICAL CHEMISTRY TEST CEK SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 120243 00630414279206

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female