BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLE CELL BUFFER

    MDR report key: 310967 · Received January 4, 2001

    Report

    Report Number
    MW1020748
    Event Type
    Malfunction
    Date Received
    January 4, 2001
    Date of Event
    December 18, 2000
    Report Date
    January 4, 2001
    Manufacturer
    COLUMBIA DIAGNOSTICS
    Product Code
    GHM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REAGENT USED FOR SICKLE CELL TESTING. MFR INSTRUCTIONS STATE RESULT CAN BE READ WITHIN 2 TO 5 MINS. RPTR READ A POSITIVE AT 5 MINS AND ELECTROPHORESIS GAVE NORMAL RESULT (NEG). THE FOLLOWING DAY 2 OTHERS GAVE SAME RESULTS. CONTACT MFR THAT ADMITTED THAT LOT NUMBER WAS SLOW. A 4TH TEST WAS TOTALLY POSITIVE AT 5 MINS BUT NEGATIVE BY EIGHT MINS. MFR SUGGESTED TO WAIT 15 MINS FOR THIS LOT. MFR TO SEND A SUBSTITUTE LOT BUT RPTR HAS NOT YET RECEIVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347 SICKLE CELL BUFFER TESTING REAGENT GHM COLUMBIA DIAGNOSTICS NA 0272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA