BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT LIPOPROTEIN (A) GEN. 2

    MDR report key: 20313080 · Received September 26, 2024

    Report

    Report Number
    1823260-2024-02793
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DFC
    UDI-DI
    07613336140833
    PMA / PMN Number
    K122722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE LPA2 TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULT OF 493 NMOL/L. THE LPA2 RESULT OF 669 NMOL/L WAS OBTAINED ON (B)(6) 2024 AND WAS FROM A NEW PATIENT SAMPLE. THE INVESTIGATION FOUND THAT THE DISCREPANT RESULTS WERE FROM VASCULAR SURGERY PATIENTS WHO HAD VERY HIGH LPA2 CONCENTRATIONS ABOVE THE MEASURING RANGE. ALL SAMPLES WERE ABOVE OR VERY CLOSE TO THE HIGH DOSE HOOK LIMIT OF THE ASSAY. PER PRODUCT LABELING, "HIGH DOSE HOOK-EFFECT: NO FALSE RESULT OCCURS UP TO A LIPOPROTEIN (A) CONCENTRATION OF 450 NMOL/L." BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6).

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD H2 TYPE OF FOLLOW UP WAS UPDATED FOR THE INITIAL FOLLOW-UP REPORT SUBMITTED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LPA2 TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULTS FOR SEVERAL PATIENT PLASMA SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER PROVIDED EXAMPLES FOR 2 PATIENT SAMPLES. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL LPA2 RESULT ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 707 NMOL/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AND THE RESULT WAS 437 NMOL/L ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS AUTO-REPEATED AND THE RESULT WAS 493 NMOL/L. A 1:3 DILUTION WAS MADE FROM THE PATIENT SAMPLE AND TESTED AND THE RESULT WAS 441 NMOL/L. THE PATIENT ALSO HAD ANOTHER SAMPLE RESULT OF 669 NMOL/L. CLARIFICATION ON THE DATE OF TESTING AND IF IT WAS OBTAINED FROM A SAMPLE FROM THE SAME COLLECTION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611028 TINA-QUANT LIPOPROTEIN (A) GEN. 2 LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL DFC ROCHE DIAGNOSTICS 78461901 07613336140833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown