BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE9NC COAGULATION SODIUM CITRATE 3.2% 13X75

    MDR report key: 11685637 · Received April 19, 2021

    Report

    Report Number
    8020040-2021-00017
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    May 18, 2021
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Removal / Correction Number
    21-001 RES 87660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INITIATION OF THE RECALL 21-001 RES87660 2 COMPLAINTS (CO21-2100-224 AND CO21-2100-246) WERE RECEIVED. THE CUSTOMERS WERE NOTIFIED OF THE RECALL AND HAVE RETURNED THE PRODUCT DISPOSITION SITE CONFIRMATION FORM. THE INVESTIGATION DETERMINED THAT THE DRAW VOLUME LOSS IS RELATED TO INSUFFICIENT STORAGE TIME OF COMPONENTS IN MANUFACTURING. THIS CAN LEAD TO AN INITIAL DROP IN TUBE VACUUM AND REDUCES THE NOMINAL DRAW VOLUME OF THE COAGULATION TUBE. WHILE CLSI* ALLOWS A -10% TOLERANCE FOR DRAW VOLUME, SOME OF THE RECALLED COAGULATION TUBES CAN HAVE A VACUUM LOSS OF -20%. FOR CORRECTION, THE COMPONENT STORAGE TIMES IN MANUFACTURING WERE EXTENDED, AND ADDITIONAL TESTING WAS PUT IN PLACE TO ENSURE THAT THE ISSUE IS CORRECTED. CORRECTED DATA: H6: INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; ADDITIONAL DATA: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    PROCESS CHANGE CAUSES DECREASE IN DRAW VOLUME. A DETAILED ROOT CAUSE INVESTIGATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING THE PROCESS OF MARKET SURVEILLANCE IN MARCH 2021, WE HAVE BECOME AWARE THAT SOME ITEM AND LOT NUMBERS OF 3.2% 9NC COAGULATION SODIUM CITRATE TUBES MAY SHOW INSUFFICIENT DRAW VOLUME OF THE TUBES. THE 3.2% 9NC COAGULATION SODIUM CITRATE TUBE IS USED TO MONITOR ANTICOAGULANT THERAPY, SUCH AS HEPARIN OR WARFARIN. AN INSUFFICIENT DRAW VOLUME MAY BE DETECTED BY THE USER (I.E. PHLEBOTOMIST, NURSE) DURING ROUTINE VENIPUNCTURE. THE LOWER FILL-VOLUME WOULD LEAD TO AN INCREASE OF CITRATE CONCENTRATION. PHLEBOTOMISTS AND LABORATORY TECHNICIANS CAN DETECT THE LOWER AMOUNT OF TOTAL FILL-VOLUME BASED ON THE FILL LEVEL GUIDANCE LOCATED ON THE TUBE. TUBES WHICH FILL BELOW THE RECOMMENDED 90% FILL LEVEL SHOULD BE DISCARDED AND NOT USED. DEPENDING ON THE DEGREE OF UNDERFILLING, IT MAY LEAD TO ARTIFICIALLY PROLONGED PT AND/OR PTT AND ERRONEOUS FIBRINOGEN RESULTS. THIS COULD RESULT IN THE WITHHOLDING OR LOWERING THE DOSE OF HEPARIN OR WARFARIN, OR THE ADMINISTRATION OF VITAMIN K IN A PATIENT WITH THERAPEUTIC LEVELS OF ANTICOAGULANT. THIS IN TURN COULD LEAD TO A POTENTIAL THROMBOTIC EVENT. CLINICAL LABORATORY PRACTICE SHOULD VERIFY ANY CHANGE IN PATIENTS' PRIOR TEST RESULTS BEFORE ADJUSTMENTS OF ANTICOAGULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588570 VACUETTE TUBE9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE GMBH 454322, 454332, 454334 A21023B5, A210338Q, A210233V

    Patients

    Seq Age Sex Outcome Treatment
    1