BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16436897 · Received February 24, 2023

    Report

    Report Number
    1125230-2023-00010
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Report Date
    March 22, 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

    RECEIVED 20PCS 455071P/B22103HU AND 15PCS 455071P/B2211339 FOR EVALUATION. RECEIVED CUSTOMER PICTURE. WE HAVE NO FURTHER COMPLAINTS FOR EITHER OF THE CLAIMED MATERIAL/BATCHES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERRORS. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY AND ADDITIVE CONTENT ACCORDING TO ISO 6710 'SINGLE USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION' AND CLSI GP39-A6 REGULATIONS FOR 'EVACUATED TUBES AND ADDITIVES FOR BLOOD SPECIMEN COLLECTION'. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. ADDITIONALLY, 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 ALLEGED MALFUNCTION IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). SAMPLES FROM THE CUSTOMER WERE ONLY RECENTLY RECEIVED AND THEIR EVALUATION IS TILL IN PROGRESS. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES THEY ARE STILL HAVING SPECIMEN INTEGRITY ISSUES. QUEST REP HAD REACHED OUT TO PRODUCT SPECIALIST FOR TROUBLESHOOTING. CUSTOMER HAS REITERATED TO QUEST REP THEY ARE ADAMANTLY FOLLOWING ALL THE SPECIMEN COLLECTION INSTRUCTIONS, CENTRIFUGE INSTRUCTIONS, EVEN REPLACED THEIR CENTRIFUGES (CLIENT STATING THEY ARE NOW ON THEIR 5TH REPLACEMENT) - AND THEY ARE STILL EXPERIENCING THIS ISSUE - WHICH THEY FEEL IS CONFUSING SINCE THEY ARE FOLLOWING QUEST'S RECOMMENDATIONS AND THE GREINER BEST PRACTICES GUIDE. CUSTOMER STATES THAT IT DOES NOT HAPPEN ALL THE TIME, BUT FREQUENTLY. ON FEB. 6, 2023,CUSTOMER PROVIDED ADDITIONAL INFORMATION: "WE (QUEST LAB) RECEIVED A PARTIALLY SPUN SAMPLE FOR THIS ORDER, TEST WAS CMP, SO SPECIMEN INTEGRITY COMPROMISED NOTE WAS ADDED TO ORDER TO ALERT CLIENT ON HOW SAMPLE WAS RECEIVED AND HOW IT CAN CAUSE A VARIATION IN RESULTS. CMP REQUIRES A TOTALLY SPUN SAMPLE THAT DOES NOT SHOW ANY PINK TOUCH ON ARRIVAL TO LAB. PLEASE CHECK CLIENT'S CENTRIFUGE IF ITS WORKING PROPERLY OR CHECK WITH THEIR LAB IF THEY ARE RUNNING THE MACHINE THROUGH THE WHOLE CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059217 VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455071P B22103HU, B2211339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown