BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 435627 · Received December 10, 2002

    Report

    Report Number
    MW4003423
    Event Type
    Malfunction
    Date Received
    December 10, 2002
    Report Date
    December 10, 2002
    Manufacturer
    *
    Product Code
    GHQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    MISLABELED KLEINHAUER-BETKE STAIN (FETAL HEMOGLOBIN STAIN KIT). LOTS INVOLVED 92549 AND 92558. LOT 92549 HAS ALL BOTTLES IN LOT ARE LABELED AS FIXING SOLUTION WHEN ACTUALLY HALF THE BOTTLES ARE BUFFER SOLUTION. LOT 92558 HAS ALL BOTTLES LABELED AS BUFFER SOLUTION WHEN IN FACT, HALF THE BOTTLES ARE FIXING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * GHQ * * 92549
    2 * * GHQ * * 92558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA