BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT ¿2-MICROGLOBULIN

    MDR report key: 20461807 · Received October 16, 2024

    Report

    Report Number
    1823260-2024-02986
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZG
    UDI-DI
    07613336119990
    PMA / PMN Number
    K980724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE CORRECTLY PROGRAMMED ALL SPECIAL WASH FUNCTIONS BEFORE PIPETTING. CALIBRATIONS AND QCS WERE PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATIONS. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT 2-MICROGLOBULIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C 502 MODULE. PATIENT 1: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 6.4 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. PATIENT 2: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 7.2 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULT HAVING A DATA FLAG, AND HIGHER RESULTS WERE EXPECTED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582125 TINA-QUANT ¿2-MICROGLOBULIN BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM JZG ROCHE DIAGNOSTICS 76651501 07613336119990

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male