BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 ML LITHIUM HEPARIN SEPARATOR VACUETTE TOTAL CALCIUM

    MDR report key: 1039105 · Received May 6, 2008

    Report

    Report Number
    MW5006714
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Report Date
    May 5, 2008
    Manufacturer
    GREINER BIO-ONE
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE HAS BEEN A SIGNIFICANT INCREASE OF PATIENT LAB RESULTS WITH ELEVATED TOTAL CALCIUM STARTING IN 2007. I HAVE COLLECTED DATA AND HAVE COME TO THE CONCLUSION THAT THERE IS A CALCIUM CONTAMINATION ISSUE WITH THE FOLLOWING PRODUCT: 4 ML LITHIUM HEPARIN SEPARATOR VACUETTE SUPPLIED BY GREINER BIO-ONE, LOT: B010801.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 ML LITHIUM HEPARIN SEPARATOR VACUETTE TOTAL CALCIUM NONE JKA GREINER BIO-ONE B010801

    Patients

    Seq Age Sex Outcome Treatment
    1