BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT LIPOPROTEIN (A) GEN.2

    MDR report key: 23488026 · Received November 6, 2025

    Report

    Report Number
    1823260-2025-04535
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    September 26, 2025
    Report Date
    November 26, 2025
    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

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE ANALYZER WAS OPERATING WITHIN SPECIFICATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. IT WAS FOUND THAT THE CUSTOMER'S LABORATORY HUMIDITY LEVEL WAS BELOW SPECIFICATION. IT WAS ALSO FOUND THAT THE CUSTOMER HAS MULTIPLE REAGENT PACKS OPEN ON THE ANALYZER BUT ARE NOT ALL USED FOR TESTING ON A DAILY BASIS, WHICH COULD LEAD TO EVAPORATION, REAGENT CONCENTRATION, AND HIGHER REACTION LEVELS AND SAMPLE RESULTS. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH LABORATORY SPECIFIC ENVIRONMENTAL FACTORS. NO PRODUCT PROBLEM WAS IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) (LPA) GEN.2 RESULTS FOR 8 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER HAS BEEN REPEATING LPA TESTING SINCE (B)(6) 2023 DUE TO ONGOING ISSUES. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF 33.8 MG/DL WITH FLAG. THE REPEAT RESULT WAS 18.8 MG/DL. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF 93.4 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE REPEAT RESULT WAS 45.0 MG/DL WITH FLAG. ON (B)(6) 2025, SAMPLE 3 HAD AN INITIAL RESULT OF 24 MG/DL WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 93.4 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY AND 32 MG/DL. ON (B)(6) 2025, SAMPLE 4 HAD AN INITIAL RESULT OF 25 MG/DL WITH FLAG. THE REPEAT RESULT WAS 46 MG/DL. ON (B)(6) 2025, SAMPLE 5 HAD AN INITIAL RESULT OF 95 MG/DL ON MODULE 1. AN AUTOMATIC 1:3 DILUTION WAS PERFORMED ON THE SAMPLE AND THE REPEAT RESULT WAS 32 MG/DL. THE SAMPLE WAS REPEATED TWICE ON MODULE 2 AND THE RESULT WAS 27 MG/DL AND 24 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON MODULE 1 AND THE RESULT WAS 30 MG/DL. ON (B)(6) 2025, SAMPLE 6 HAD AN INITIAL RESULT OF 46 MG/DL ON MODULE 1. THE REPEAT RESULT WAS 39 MG/DL. THE SAMPLE WAS REPEATED TWICE ON MODULE 2 AND THE RESULT WAS 25 MG/DL AND 26 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON MODULE 1 AND THE RESULT WAS 28 MG/DL. ON (B)(6) 2025, SAMPLE 7 HAD AN INITIAL RESULT OF 24 MG/DL WITH FLAG. THE REPEAT RESULT WAS 58 MG/DL. ON (B)(6) 2025, SAMPLE 8 HAD AN INITIAL RESULT OF 25 MG/DL FROM MODULE 2. THE SAMPLE WAS REPEATED ON MODULE 1 AND THE RESULT WAS 46 MG/DL. THE SAMPLE WAS REPEATED TWICE ON MODULE 1 AND THE RESULTS WERE 45 MG/DL AND 58 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550894 TINA-QUANT LIPOPROTEIN (A) GEN.2 LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL DFC ROCHE DIAGNOSTICS 88726001 07613336140833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown