BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPUC3

    MDR report key: 19027099 · Received April 2, 2024

    Report

    Report Number
    1823260-2024-01014
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630925179
    PMA / PMN Number
    K071239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TPUC3 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS C701 MODULE SERIAL NUMBER WAS (B)(6) . QC WAS ACCEPTABLE. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION (SAMPLE PROBE) ALARMS. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION B7 WAS UPDATED. THE CALIBRATION WAS ACCEPTABLE. THE ALARM TRACE SHOWED FREQUENT INCUBATION WATER EXCHANGE ALARMS AND A COUPLE OF CELL BLANK ALARMS. SINCE THE PATIENT DID NOT TAKE ANY MEDICATION, NO SUBSTANCE WAS AVAILABLE THAT COULD ANALYTICALLY INTERFERE WITH THE TPUC3 ASSAY. THE ROOT CAUSE WAS CONSISTENT WITH AN ISSUE WITH THE SAMPLE QUALITY OR A POSSIBLE PHYSIOLOGICAL EFFECT OF THE PATIENT'S DISEASE CAUSING PROTEINURIA. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE ROCHE ASSAY DID NOT FUNCTION AS INTENDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 COBAS C701 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER (SIEMENS: ATHELICA SYSTEM). ON (B)(6) 2024: THE SAMPLE WAS TESTED AND THE INITIAL RESULT WAS 450 MG/DL. THE SAMPLE WAS ALSO TESTED ON SIEMENS (ATHELICA SYSTEM), RESULTING IN A TPUC3 VALUE OF 0.29 G/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED AND THE 1ST REPEAT RESULT WAS 357 MG/DL. ON (B)(6) 2024 THE SAMPLE WAS ALSO REPEATED AND THE 2ND REPEAT RESULT WAS 389 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70797 TPUC3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 730461 04015630925179

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male