BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT LIPOPROTEIN (A) GEN. 2

    MDR report key: 20091108 · Received August 28, 2024

    Report

    Report Number
    1823260-2024-02495
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 4, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DFC
    UDI-DI
    07613336140833
    PMA / PMN Number
    K122722
    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

    MEDWATCH FIELD B3 DATE OF EVENT WAS UPDATED. ADDITIONAL TESTS OF THE SAMPLE WERE PERFORMED ON 04-AUG-2024 ON ANOTHER LINE OF THE ANALYZER AND WERE 46 MG/DL, 47 MG/DL, 89 MG/DL, AND 49 MG/DL. THE RESULT OF 49 MG/DL WAS BELIEVED TO BE CORRECT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND DID NOT FIND AN ISSUE. HE PERFORMED A PRECISION CHECK THAT WAS SUCCESSFUL. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN. 2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 38 MG/DL. THE REPEAT RESULT WAS 80 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS NOT SURE WHICH RESULT WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493859 TINA-QUANT LIPOPROTEIN (A) GEN. 2 LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL DFC ROCHE DIAGNOSTICS ASKU 07613336140833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown