BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLESCREEN SICKLING HB SCREENING KIT

    MDR report key: 53215 · Received November 22, 1996

    Report

    Report Number
    1055411-1996-00001
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Date of Event
    October 25, 1996
    Report Date
    November 21, 1996
    Manufacturer
    PACIFIC HEMOSTASIS
    Product Code
    GHM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 10/25/96, TWO DISTINCT HOSP LABS REPORTED THAT 30 DETERMINATION HEMOGLOBIN SCREENING KIT LOT 250A03 (REFERRED TO AS DEVICE 1) WAS PRODUCING FALSE NEGATIVE RESULTS WITH POSITIVE PT SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SICKLESCREEN SICKLING HB SCREENING KIT IN VITRO DIAGNOSTIC TEST KIT - QUALITATIVE GHM PACIFIC HEMOSTASIS NA 250A03, 258A04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PACIFIC HEMOSTASIS CONTROL SET CAT #10-0251| DEFECT IS NOT THE RESULT OF ANY CONTROL DEFECT.| OF SUPPLIERS.| WITH POSITIVE AND NEGATIVE CONTROLS FROM A VARIETY| LAB PROFESSIONAL MONITOR SICKLESCREEN ASSAY RESULT