BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 4 ML K2E K2EDTA 13X75

    MDR report key: 15990246 · Received December 15, 2022

    Report

    Report Number
    1125230-2022-00056
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Report Date
    December 15, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT: (B)(4). WE HAVE INVESTIGATED THE CLAIM AND HAVE FOUND THE EDTA TUBES AT ISSUE HAVE BEEN INCORRECTLY USED, OR USED FOR A PURPOSE NOT INTENDED, WHICH THEREFORE LED TO INCORRECT AND FALSE LEAD TEST RESULTS. GREINER EDTA TUBES ARE NOT FDA-CLEARED FOR TESTING OF TRACE ELEMENTS, SUCH AS LEAD, NOR ARE THESE TUBES ROUTINELY VERIFIED FOR TRACE ELEMENT CONTENT. TESTING FOR LEAD AND/OR OTHER TRACE ELEMENTS IS CONSIDERED OFF-LABEL AND NOT ACCORDING TO THE INTENDED USE OF GREINER EDTA TUBES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. EXAMINATION OF 454209/B22063MH BY AN EXTERNAL INDEPENDENT LABORATORY INDICATED TRACES OF LEAD IN GREINER EDTA TUBES. WE, AGAIN, WANT TO REITERATE THAT GREINER EDTA TUBES ARE NOT ROUTINELY MONITORED FOR LEAD SINCE THEY ARE NOT INTENDED FOR TRACE ELEMENT TESTING.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THEY HAVE NOTICED AN ISSUE WITH A LARGE NUMBER OF POSITIVE BLOOD LEAD SAMPLES FROM ONE LOCATION. SINCE THIS WAS A CHANGE, EMPTY BLOOD LEAD TUBES WERE REQUESTED FROM TWO LOCATIONS. ONE SET OF TUBES CAME FROM THE LOCATION THAT WAS CONSISTENTLY GETTING ABOVE LOQ RESULTS. THE SECOND SET CAME FROM A LOCATION THAT WAS TYPICALLY RESULTING IN BELOW LOQ (CONTROL GROUP). THE CUSTOMER STATES THAT THEY THEN PLACED PROFICIENCY TESTING BLOOD SAMPLES IN THE EMPTY TUBES. THE POINT OF THE PROFICIENCY SAMPLE WAS THAT THE LAB KNOWS EXACTLY THE CONCENTRATION OF BLOOD LEAD IN THE TUBE. THE CUSTOMER STATES THAT WHAT THEY DISCOVERED IS ONE LOT OF TUBE RESULTED IN A NUMBER SIGNIFICANTLY HIGHER THAN THE TRUE RESULT OF THE PROFICIENCY SAMPLE. ALL OTHER LOTS READ AS EXPECTED BASED ON THE CONCENTRATION OF THE PROFICIENCY TEST SAMPLE. BASED ON THIS INFORMATION, THE CUSTOMER STATES THAT LOT: B22063MH NOT BE USED FOR THE COLLECTION OF BLOOD LEAD SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570345 VACUETTE® TUBE 4 ML K2E K2EDTA 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454209 B22063MH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown