BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 21688297 · Received March 25, 2025

    Report

    Report Number
    1823260-2025-00869
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 5, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    07613336121535
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, LOT NUMBER AND EXPIRATION DATE WERE UPDATED. A 2ND URINE SAMPLE FROM THE PATIENT WAS OBTAINED, AND THE TPUC3 RESULT WAS 3.32 G/L. THE INITIAL REPORT STATED: "THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).". CLARIFICATION WAS RECEIVED THAT THIS SHOULD SAY: "THE C503 ANALYZER SERIAL NUMBER WAS (B)(6)." REPEAT TESTING WAS PERFORMED ON C503 ANALYZER SERIAL NUMBER (B)(6). THE INITIAL RESULT OF > 2.00 G/L WAS ACCOMPANIED BY AN INVALIDATING DATA FLAG (>TEST).

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE SHOWED SEVERAL "SAMPLE SHORT" AND "ABNORMAL ASPIRATION" ALARMS AROUND THE TIME OF THE EVENT. QC RESULTS WERE STABLE, WITH RESULTS SLIGHTLY ABOVE THE TARGET VALUE. A FULL CALIBRATION WAS PERFORMED IN SEP-2024. THE FIRST TWO CALIBRATIONS HAD ALARMS; THE THIRD CALIBRATION WAS SUCCESSFUL. THE REPEAT RESULT OF 7.55 G/L WITH A X20 DILUTION WAS ACCOMPANIED BY A DATA ALARM THAT INDICATED THE REAGENT WAS STORED OR HANDLED IMPROPERLY OR HAD DETERIORATED. THE INITIAL SAMPLE WAS NOT HANDLED ACCORDING TO SPECIFICATION. THE CENTRIFUGATION TIME AND G-FORCE SPECIFIED BY THE MANUFACTURER (10 MINUTES AT 1300-2000G) WERE NOT FOLLOWED, AS THE CUSTOMER USED A G-FORCE OF 2500G FOR 11 MINUTES. AN EXPECTED RESULT WAS RECEIVED FOR THE 2ND SAMPLE FROM THE PATIENT. AS THE CUSTOMER HAD NO ISSUES WITH OTHER PATIENT SAMPLES AND THE RESULT FROM A 2ND SAMPLE FROM THIS PATIENT WAS ACCEPTABLE, THE EVENT IS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 2.00 G/L. THE REPEAT WITH A X20 DILUTION WAS 7.55 G/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 1.49 G/L. NONE OF THE RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED AS THE RESULTS WERE INCONSISTENT WITH THE URINE ALBUMIN RESULT OF > 400 (UNIT OF MEASURE NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133105 TOTAL PROTEIN URINE/CSF GEN.3 URINE/CSF TOTAL PROTEIN TEST JIQ ROCHE DIAGNOSTICS 813681 07613336121535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown