BEUDAMED
    FDA Adverse Event Other Summary report: N

    RBC PLATELET DILUENT

    MDR report key: 116170 · Received August 25, 1997

    Report

    Report Number
    1810909-1997-00012
    Event Type
    Other
    Date Received
    August 25, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 18, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    GIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINTS WERE REC'D WHICH INDICATED CUSTOMERS WERE EXPERIENCING BOTTLE TO BOTTLE VARIATION IN WHICH SOME BOTTLES WERE ASSOCIATED WITH THE PRESENCE OF A SPIKE IN THE PLATELET HISTOGRAM. THIS SPIKE MAY CAUSE AN FALSE EVALUATION OF UP TO 30,000 TO 80,000 PLATELETS/UL. AN EVALUATION OF PLATELET RESULTS IS CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RBC PLATELET DILUENT DILUENT GIF BAYER CORP. T01-1570-56 V01894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA