BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICOLLECT TUBE 1ML 9NC COAGULATION 3.2% LIGHT BLUE

    MDR report key: 10423192 · Received August 18, 2020

    Report

    Report Number
    8020040-2015-00023
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    August 18, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    JKA
    PMA / PMN Number
    K992244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT (B)(4). RECEIVED LOOSE PC 450413/141105 FOR EVALUATION. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINT ON THIS MATERIAL/BATCH. ACCORDING TO THE INVESTIGATION AND COMMENTS, WE ARE UNABLE TO FIND ANY DEVIATIONS THAT WOULD RESULT IN ERRONEOUS FIBRINOGEN RESULTS. PH AND ADDITIVE CONTENT WERE BOTH FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY HAVE HAD SOME ERRONEOUS FIBRINOGEN RESULTS. WITH SOME PATIENTS, THE INITIAL FIBRINOGEN RESULTS REPORTED OUT BY THE STAGO COMPLETE ANALYZER MAY BE HIGH (I.E. OVER 500MG/DL), THEN THE REPEAT OF THE SAME SPECIMEN REPORTS OUT AS 1/2 TO 1/3 LESS THEN THE INITIAL RESULTS (I,E 200MG/DL). SOME SAMPLES HAVE BEEN CHECKED ON A DIFFERENT STAGO COMPLETE AT A SISTER FACILITY AND WERE FOUND TO BE NORMAL (CONSISTENT WITH THE REPEATED RESULTS). THE PATIENT POPULATION IS PRIMARILY PEDIATRIC CARDIAC PATIENTS WHO ARE UNDERGOING OPEN HEART SURGERY, ARE ON THE BYPASS MACHINE, ARE RECEIVING UNFRACTIONATED HEPARIN, AND MAY ALSO BE RECEIVING BLOOD PRODUCTS AT THE TIME OF COLLECTION. SAMPLES ARE PRIMARILY DRAWN FROM LINES AND ARE CENTRIFUGED WITHIN TEN MINUTES AFTER COLLECTION IN A STATSPIN, 30 DEGREE FIXED ANGLE FOR 3 MINUTES AT 7200 RPM (4440 G), WHICH IS THE RECOMMENDATION BY THE REAGENT MANUFACTURER. ERRONEOUS RESULTS WITH OTHER COAG TESTS PERFORMED FROM THE SAME PATIENT SPECIMENS DEMONSTRATING THE ERRONEOUS FIBRINOGEN RESULTS HAVE NOT BEEN DETECTED (PT, PTT, ANTI-XA, AND ANTITHROMBIN III).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883075 MINICOLLECT TUBE 1ML 9NC COAGULATION 3.2% LIGHT BLUE GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE JKA GREINER BIO-ONE GMBH 450413 141105

    Patients

    Seq Age Sex Outcome Treatment
    1