BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 20526861 · Received October 24, 2024

    Report

    Report Number
    1823260-2024-03071
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 25, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    07613336121535
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE TPUC3 REAGENT LOT NUMBER WAS 783083 WITH AN EXPIRATION DATE OF 31-MAY-2025. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTIONS D1, D2A, D2B, D4, G1 AND G4 WERE UPDATED. THE QC WAS PROVIDED FOR (B)(6) 2024 AND(B)(6) 2024 AND IT WAS ACCEPTABLE. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE CALIBRATION DATA WAS UNREADABLE AND WAS NOT EVALUATED. THE ALARM TRACE SHOWED ABNORMAL ASPIRATION AND LIQUID LEVEL ALARMS WHICH CAN BE AN INDICATION OF POOR SAMPLE QUALITY. THE CUSTOMER MENTIONED THE RESULTS APPEARED TO BE DUE TO A TECHNICAL ERROR IN THE DILUTION PROTOCOLS. THE FIELD SERVICE ENGINEER (FSE) PERFORMED HARDWARE CHECKS AND VERIFIED THAT THE SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS. PRECISION STUDIES WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. THE TROUBLESHOOTING ACTIONS PERFORMED BY THE CUSTOMER AND THE FSE RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO A USER ERROR (TECHNICAL ERRORS IN FOLLOWING THE DILUTION PROTOCOLS).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH CREATININE ASSAY AND TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS C503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THAT THE URINE TOTAL PROTEIN/CREATININE RATIO RESULT WAS ALSO DISCREPANT. CREATININE: INITIAL RESULT: 114.0 MG/DL. REPEAT RESULT: 5.15 MG/DL. TPUC3: INITIAL RESULT: 363 MG/DL (ACCOMPANIED BY AN INVALIDATING FLAG). THE SAMPLE WAS AUTO-REPEATED. 1ST REPEAT RESULT: 117 MG/DL (AUTO-REPEATED AND ACCOMPANIED BY AN INVALIDATING FLAG). THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER NOTICED THE AUTO-REPEAT, QUESTIONED THE RESULT, AND REPEATED THE SAMPLE USING MANUAL DILUTION. 2ND REPEAT RESULT: 37 MG/DL (TESTED WITH MANUAL DILUTION AND REPORTED OUTSIDE THE LABORATORY). THE FINAL RESULT WAS 1845 MG/DL. THE RESULT OF 1845 MG/DL WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772018 TOTAL PROTEIN URINE/CSF GEN.3 URINE/CSF TOTAL PROTEIN TEST JIQ ROCHE DIAGNOSTICS 783083 07613336121535

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female