BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML LH LITHIUM HEPARIN SEPARATOR 13X75

    MDR report key: 21848296 · Received April 16, 2025

    Report

    Report Number
    1125230-2025-00011
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Report Date
    May 18, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): NO SAMPLES OF 454247P/B241033Q WERE RECEIVED FROM THE CUSTOMER. NO CUSTOMER PICTURES WERE PROVIDED. PLEASE ADVISE THE CUSTOMER THAT WE MUST HAVE SAMPLES RETURNED FOR QUALITY ASSURANCE SO THAT A PROPER INVESTIGATION MAY BE CONDUCTED. SHOULD THE CUSTOMER ENCOUNTER ANY ISSUES IN THE FUTURE, PLEASE ADVISE THEM TO SAVE THE SAMPLES FOR INVESTIGATIVE PURPOSES. RECEIVED 32 RACKS 454247P/B2411345 FOR EVALUATION. WE HAVE NO REMAINING INVENTORY OF EITHER MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY AND ADDITIVE CONTENT. TUBES WERE VERIFIED TO BE FREE OF ANY VISUAL DEVIATIONS ASSOCIATED WITH THE CLAIMED ERROR. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THEY RECENTLY EXPERIENCED FALSELY ELEVATED TROPONINS THAT THROUGH PROCESS OF ELIMINATION, DETERMINED WERE LIKELY DUE TO FIBRIN PRESENT IN SPECIFIC LOTS OF LITHIUM HEPARIN TUBES. CUSTOMER ADVISED ONCE THEY DISCOVERED THE PROBLEM, THEY BEGAN DOUBLESPINNING THE TUBES, CHECKING THE PLASMA CAREFULLY FOR FIBRIN, AND ALWAYS PIPETTING INTO A CLEAR INSERT CUP [ALIQUOT CUP] PRIOR TO ANALYSIS. NONETHELESS, IT RECURRED ANOTHER 4 TIMES BEFORE THEY ISOLATED THE TUBES AND REMOVED THEM FROM CIRCULATION. CUSTOMER ADVISED THE FIRST PATIENT WAS ADMITTED - LIKELY DUE TO THE HIGH TROPONIN-I, AND SINCE THEN, ALL CORRECTED IN REAL TIME AS THEY IMPLEMENTED A POLICY TO REPEAT ALL HIGH TROPONIN SAMPLES FOR PATIENTS WHO HAD NO PRIOR HISTORY. THEY ALSO PERFORMED PRECISION AND REPRODUCIBILITY TESTS ON OUR ANALYZERS. ALL WERE WITHIN ACCEPTABLE LIMITS. CUSTOMER ADVISED THEY USE BECKMAN COULTER'S ACCESS2 ANALYZER FOR TROPONIN TESTING AND HAD 6 DOCUMENTED CASES WHERE THE TROPONIN WAS FALSELY ELEVATED SINCE (B)(6) 2025. PER CUSTOMER ALL SAMPLE TUBES WERE FILLED TO THE INDICATOR, STAFF WAS TRAINED TO INVERT THEIR TUBES. CENTRIFUGE USED: HETTICH ROTINA 380, RCF=2143 RPM=3000 FOR 5 MIN. SPECIMEN TUBES WERE AMBIENT. NO PHOTOGRAPHS ARE AVAILABLE OF THE SAMPLE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111343 VACUETTE® TUBE 3 ML LH LITHIUM HEPARIN SEPARATOR 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NORTH AMERICA, INC 454247P B241033Q, B2411345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown