BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES SERUM PRODUCT GROUP

    MDR report key: 17444370 · Received August 2, 2023

    Report

    Report Number
    1125230-2023-00041
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    September 13, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED. ENDEAVORS TO RECEIVE MORE INFORMATION REGARDING THE MATERIAL NUMBERS, BATCHES AS WELL AS SAMPLES AND/OR PHOTOS ARE ONGOING. AS SOON AS OUR INVESTIGATON IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED 5PCS OF 456073P/B23033T8 AND 1PC OF 454067P/B221233X, WHICH WERE TUBES CUSTOMER HAD ON HAND DURING AN ONSITE VISIT CONDUCTED BY GBO PERSONNEL. RECEIVED OBSERVATION REPORT FROM THE ONSITE VISIT PERFORMED ON AUGUST 15-16, 2023. CUSTOMER COULD NOT CONFIRM WITH WHICH MATERIAL(S)/BATCH(ES) THEY EXPERIENCED CLAIMED ISSUES. CUSTOMER REPORTED ISSUES ALSO OCCURRING WITH COMPETITOR TUBES. THE CAUSE OF THE EVENT CANNOT BE DETERMINED. CORRECTED DATA: H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ASPIRATION ERRORS AND SPURIOUS RESULTS ON THEIR COBAS PRO ANALYZER WITH VACUETTE® CAT SERUM SEPARATOR CLOT ACTIVATOR TUBES. THE CUSTOMER REPORTED THE PRESENCE OF UNIDENTIFIED DROPLET PARTICLES FLOATING IN THE UPPER PORTION OF THE SPECIMEN TUBES. THE DROPLETS ARE SEEN ON THE ROCHE COBAS PRO VIA A CAMERA SYSTEM. THE CUSTOMER ADVISED THE TUBES CLOTTED FOR 30 MINUTES PRIOR TO CENTRIFUGATION AND CENTRIFUGED AT 3500 RPM FOR 10 MINUTES. THE CUSTOMER REPORTED SPURIOUS RESULTS EXPERIENCED ON THEIR ISE TESTS. ASPIRATION ERRORS OCCURRED ON TUBES FILLED COMPLETELY WITH AN AVERAGE FREQUENCY OF TEN PER DAY. THE CUSTOMER REPORTED A DECREASE IN FREQUENCY IN SPURIOUS RESULTS AFTER CHANGING THEIR CENTRIFUGE, BUT THE ASPIRATION ERROR FREQUENCY REMAINED CONTINUED. THE CUSTOMER REPORTED OTHER LABORATORY LOCATIONS IN THEIR NETWORK USE A COBAS 6000 ANALYZER WITH PREDOMINATELY PLASMA SEPARATOR TUBES. THE CUSTOMER REPORTED THESE LOCATIONS ARE NOT EXPERIENCING ASPIRATION ERRORS AND SPURIOUS RESULTS WITH THE COBAS 6000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797200 VACUETTE BLOOD COLLECTION TUBES SERUM PRODUCT GROUP EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown