BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3.5 ML LH LITHIUM HEPARIN SEPARATOR 13X100

    MDR report key: 21945873 · Received May 1, 2025

    Report

    Report Number
    1125230-2025-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 28, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): RECEIVED 1RK (B)(6) FOR EVALUATION. RECEIVED CUSTOMER PICTURES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE RE-PORTED ERROR. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED WITH NO "DEBRIS" OBSERVED. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TEST-ED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. SAMPLES WERE FUNCTIONALLY EVALUATED (FILLED AND CENTRIFUGED AT 1800G FOR 10MIN - MINIMUM OF RECOM-MENDED CONDITIONS). NO DEVIATIONS COULD BE OBSERVED IN TESTED SAMPLES. THE COMPLAINT CANNOT BE CONFIRMED. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER AND HAVE BEEN RECEIVED, THEY HAVE NOT YET BEEN EVALUATED AS OF THIS REPORT. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES FALSELY ELEVATED TROPONINS RUN ON THE ROCHE E801 COBAS PRO. WHEN THE TESTS ARE REPEATED ON THE SAME TUBE, LOWER RESULTS ARE OBTAINED IN LINE WITH WHAT IS EXPECTED. WHEN ROCHE WAS CONTACTED FOR TROUBLESHOOTING, THEIR INVESTIGATION SHOWED THE CAMERA ON THE ANALYZER IS PICKING UP DEBRIS, BUT THE ONLY ERRONEOUS RESULT IS WITH TROPONIN. NO OTHER TEST RESULTS ARE AFFECTED. NO ERROR MESSAGE IS TRIGGERED BY THE DEBRIS PICKED UP BY THE CAMERA. THE ACCOUNT HAS THREE E801 ANALYZERS. CUSTOMER SAYS HE WILL TRY TO OBTAIN THE CAMERA IMAGES FROM HIS ROCHE FIELD SERVICE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195298 VACUETTE® TUBE 3.5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 EVACUATED BLOOD COLLECTION TUBE, JKA GREINER BIO-ONE NORTH AMERICA, INC 456287P B2409354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown