BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    MDR report key: 17372565 · Received July 21, 2023

    Report

    Report Number
    1125230-2023-00036
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Report Date
    July 21, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4). RECEIVED 4PCS 455071P/B23023BY FOR EVALUATION. RECEIVED CUSTOMER PICTURE. ALSO RECEIVED 3PCS 455071P/B220534G, 2PCS 455071P/B22113RG, 2PCS 455071P/B2211339 AND 1PC 455071P/B2211336, WHICH WERE UNRELATED TO THE COMPLAINT. WE HAVE NO REMAINING INVENTORY OF THE CLAIMED MATERIAL/BATCH. CUSTOMER SAMPLES WERE VISUALLY INSPECTED, AND NO DEVIATIONS WERE OBSERVED. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. ADDITIONALLY, SELECTED SAMPLES WERE FILLED AND PLACED IN A CENTRIFUGE FOR 10 MINUTES AT 1800G. CORRECT GEL FUNCTION WAS VERIFIED, AND NO DEVIATIONS WERE OBSERVED DURING OR AFTER THE CENTRIFUGATION PROCESS. THE COMPLAINT IS NOT CONFIRMED AND THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES ONE OF THEIR CLIENTS IS RECEIVING "COMPROMISED SPECIMEN" ERRORS. THIS MESSAGE IS GENERATED WHEN "WHOLE BLOOD, UNSPUN, OR PARTIALLY SPUN GEL BARRIER TUBE IS RECEIVED MORE THAN 6 HOURS SINCE COLLECTION, CAUSING RED CELLS TO BE IN CONTACT WITH THE SERUM OR PLASMA." CLIENT CONFIRMS THAT SERUM GEL TUBES ARE SENT TO QUEST LAB ALREADY SPUN. SERUM AND GEL INTEGRITY ARE IN QUESTION. CUSTOMER STATES THAT 10 TUBES WERE AFFECTED IN THE LAST 90 DAYS FOR THIS CLIENT. THE TUBES ARE INVERTED 5-10 TIMES AFTER COLLECTION. THE SPECIMENS ARE ALLOWED TO CLOT THOROUGHLY (MINIMUM 30 MINUTES) AFTER BLOOD COLLECTION BEFORE CENTRIFUGATION. THE SPECIMENS ARE SPUN AT QUEST'S RECOMMENDED TIME AND SPEED (15 MIN FOR 1600G).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922378 VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455071P B23023BY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown