BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

    MDR report key: 10770989 · Received November 2, 2020

    Report

    Report Number
    1125230-2018-00011
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    December 17, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S NARRATIVE: WE COULD NOT OBTAIN A DATE OF EVENT. THE MDR IS SUBMITTED RETROSPECTIVELY. CORRECTED DATA: CHECKED NOTIFICATION IN H7 WAS REMOVED, NOTIFICATION WAS ENTERED ERRONEOUSLY. ADDITIONAL STATEMENT TO MANUFACTURER'S NARRATIVE.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). RECEIVED 18 LOOSE TUBES 454246/B1805347 FOR EVALUATION. (ALSO RECEIVED 454246: 10 TUBES B18033LM, 1 TUBE B180435H AND 1 TUBE B180435J. NONE LISTED ON COMPLAINT.) WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. THE COMPLAINT IS CONFIRMED. WE HAVE ALREADY PERFORMED AN INVESTIGATION AND RECOMMEND THE USE OF LITHIUM HEPARIN TUBES FOR AMMONIA ANALYSIS. EDTA TUBES ACCORDING TO GREINER IFU ARE FOR ROUTINE IMMUNOHEMATOLOGY TESTING, RH TYPING AND ANTIBODY TESTING, VIRAL MARKER TESTING, AND TESTING PLASMA IN MOLECULAR DIAGNOSTICS; K014104 MOLECULAR DIAGNOSTICS; K971236 ROUTINE HEMATOLOGY: BK030032 IMMUNOHEMATOLOGY; BK040018 VIRAL MARKERS.

    Description of Event or Problem · 1

    CUSTOMER ADVISED THAT TESTING THE VACUETTE® K2EDTA TUBES SHOW THE PRESENCE OF AMMONIA. CUSTOMER STATED A PHYSICIAN QUESTIONED A PATIENT'S AMMONIA RESULTS AS BEING FALSELY HIGH. THE LAB PERFORMED SEVERAL EXPERIMENTS WHEN THE ISSUE WAS RAISED. FIRST, THEY TOOK AN EMPTY POLYPROPYLENE TUBE, PLACED SOME DISTILLED WATER IN THE TUBES AND TESTED FOR AMMONIA AND THE RESULT WERE 0 MOL/L. NEXT, THEY TOOK K2EDTA TUBES IN QUESTION, REMOVED THE CAPS, AND PLACED VARYING AMOUNTS OF DISTILLED WATER INTO THE TUBES. IN THE TUBE WITH 0.5ML OF DISTILLED WATER THE RESULT OF 42 MOL/L WAS OBTAINED. THE TUBE WITH 1.0ML DISTILLED WATER HAD A RESULT OF 21 MOL/L. THE TUBES WITH 1.5ML AND 2.0ML DISTILLED WATER YIELDED 10 MOL/L AND 3 MOL/L RESPECTIVELY. CUSTOMER REVIEWED 235 RECENT PATIENT RESULTS AND 70 RESULTS WERE FOUND TO BE IN THE PUBLISHED REFERENCE RANGE/EXPECTED VALUES 16-53 MOL/L. CUSTOMER USES THE BECKMAN COULTER AU5800. CUSTOMER ADVISED THEY PROCESS THE SPECIMENS PER BECKMAN'S IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233690 VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454246 B1805347

    Patients

    Seq Age Sex Outcome Treatment
    1