BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100

    MDR report key: 11678954 · Received April 16, 2021

    Report

    Report Number
    1125230-2021-00032
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Report Date
    May 13, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 2RK OF 456087P/B210137G FOR EVALUATION. RECEIVED CUSTOMER PICTURES AND VIDEOS. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. 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 GUIDELINE 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 TESTED SAMPLES. SOME OF THE SAMPLES WERE EVALUATED IN A BLOOD DRAW. SAMPLES WERE CENTRIFUGED USING RECOMMENDED GBO PARAMETERS WITHIN 2 HOURS. NO OILY RESIDUE ON THE TOP SURFACE OF THE PLASMA, GEL DROPLETS, AND FIBRIN AS DESCRIBED BY THE CUSTOMER COULD BE OBSERVED. THE COMPLAINT CANNOT BE DUPLICATED ON THE RETURNED SAMPLES. CORRECTED DATA: H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION. H10: MANUFACTURERER NARRATIVE.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE RECEIVED, BUT THE EVALUATION IS STILL IN PROGRESS. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY STATED THEY ARE SEEING CELLULAR DEBRIS IN TUBES AFTER CENTRIFUGATION, AS WELL AS SOMETIMES INCOMPLETE SEPARATION. CUSTOMER STARTED SEEING ISSUES IN THE LAST 6 MONTHS. ROCHE COBAS IS THE ANALYZER IN USE AND ALK PHOS RESULTS, AND OTHER TESTS, ARE BEING AFFECTED. DURING A FOLLOW-UP CONVERSATION BY GREINER WITH THE CUSTOMER, IT WAS STATED THAT NO CELLULAR DEBRIS OR INCOMPLETE SEPARATION IN TUBES AFTER CENTRIFUGATION HAS BEEN OBSERVED. THE ANALYZER COMPANIES MAINTAIN THAT THE ISSUE IS NOT CAUSED BY THE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580223 VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR 13X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456087P B210137G

    Patients

    Seq Age Sex Outcome Treatment
    1