BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING,

    MDR report key: 10919269 · Received November 30, 2020

    Report

    Report Number
    1125230-2020-00060
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Report Date
    December 21, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GBO COMPLAINT (B)(4): THE DATE OF EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. RECEIVED 1RK 456087P/B20083XL, 1RK 456087P/B200849P, AND THREE LOOSE TUBES 456087P/B20083T6 FOR EVALUATION. A REVIEW OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS SHOWS NO DEVIATIONS IN RELATION TO THE REPORTED ISSUE. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, LEVEL MARK, FILLING LEVEL, DRAW VOLUME 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'. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED AND HAD THE CORRECT FILL GUIDE LINE POSITION. GREINER FILL MARK PROVIDES A VISUAL CONTROL OPPORTUNITY FOR THE PHLEBOTOMIST AND FOR THE LAB PERSONNEL TO CHECK FOR PROPER VOLUME COLLECTION OF SPECIMEN. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. NO DEVIATIONS COULD BE OBSERVED IN THE SAMPLES. COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT (B)(4). WE HAVE NO FURTHER INVENTORY OF THE MATERIAL AND BATCHES. CUSTOMER SAMPLES ARE STILL UNDER INVESTIGATION. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENT REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ST. JOSEPH'S LABORATORY SYSTEM (FIVE SITES) CONVERTED TO GREINER TUBES IN MAY 2020. SINCE THE CONVERSION CUSTOMER STATES THE LABS HAVE EXPERIENCED INCREASES IN HEMOLYSIS. CUSTOMER HAS PROVIDED SOME DATA SHOWING THE INCREASES. HEMOLYSIS DATA IS COLLECTED IN THE AGGREGATE OF CHEMISTRY SPECIMENS AND NOT DOCUMENTED BY PRODUCT ITEM AND LOT NUMBERS. CUSTOMER CONFIRMED THAT THE SAME COLLECTION, HANDLING, AND PROCESSING OF PATIENT SPECIMENS OCCUR WITH THE GREINER TUBES AS WITH THE BD TUBES PRIOR. CUSTOMER NOTIFIED GREINER IN JUNE 2020 (B)(4) OF THE INCREASE BUT WITH NO DETAILED INFORMATION. CUSTOMER HAD A CONFERENCE CALL WITH GREINER IN SEPTEMBER 2020 TO DISCUSS HEMOLYSIS, THE REPORT FROM (B)(4), AND NEXT STEPS. CUSTOMER HAS NOTIFIED THE SITES NOT TO DOUBLE SPIN (RE-CENTRIFUGE) SPECIMENS PER OUR IFU. CUSTOMER HAS PROVIDED SOME ADDITIONAL INFORMATION BY LABORATORY SITE. BASED ON CERTAIN HEMOLYSIS INDEX LEVELS SEEN (VARIES BY LAB) THE LAB WILL CANCEL THE PATIENT'S RESULTS AND REDRAW. CUSTOMER ADVISES THIS IS A CRITICAL MATTER AS IT IMPACTS PATIENT CARE WHEN REDRAWS ARE REQUIRED. GREINER IS WORKING WITH THE CUSTOMER ON COLLECTION METHODS USED AS THERE IS INDICATION THAT THIS MAY BE A CONTRIBUTING FACTOR TO THE INCREASE IN HEMOLYSIS SEEN. ANN ARBOR LABORATORY PRIMARY TUBES USED IS THE LITHIUM HEPARIN GEL TUBE FOR CHEMISTRY AND THESE ARE CENTRIFUGED AS PART OF THE BECKMAN COULTER POWER PROCESSOR AUTOMATION LINE AT 3000 RPMS FOR SIX MINUTES. LAB RECEIVES IN PATIENT SPECIMENS THROUGH A PNEUMATIC SYSTEM AND OUTPATIENT SPECIMENS FROM VARIOUS SITES SO CENTRIFUGATION WITHIN TWO HOURS IS DEPENDENT UPON WHERE THE SPECIMENS ORIGINATE. COLLECTION METHOD IS PRIMARILY STRAIGHT NEEDLE. CUSTOMER STATES MIXING MAY VARY DEPENDING ON THE COLLECTION SITE. THE LABORATORY USES THE BECKMAN COULTER HEMOLYSIS INDEX FOR HEMOLYSIS; 0-3 RESULTS, 4-7 RESULTS WITH COMMENTS, 10> CANCELLED AND REDRAW. CUSTOMER PROVIDED LIST OF RECENT LOTS WHERE HEMOLYSIS INDEX WAS 10 OR GREATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384476 VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 GREEN CAP-YELLOW RING, EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456087P B20083XL, B20083TL, B200849P

    Patients

    Seq Age Sex Outcome Treatment
    1