BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICKLESCREEN SICKLING HB SCREENING KIT

    MDR report key: 59049 · Received December 18, 1996

    Report

    Report Number
    1055411-1996-00005
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    November 19, 1996
    Report Date
    December 12, 1996
    Manufacturer
    PACIFIC HEMOSTASIS
    Product Code
    GHM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/19/96, A HOSP LAB REPORTED THAT 30 DETERMINATION DIAGNOSTIC TEST KIT LOT 258A04 WAS PRODUCING FALSE NEGATIVE RESULTS WITH POSITIVE CONTROLS.

    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 258A04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other PACIFIC HEMOSTASIS CONTROL SET CAT 10-0251| DEFECT NOT RESULT OF CONTROL DEFECT| ASSAY MONITORED WITH NEG CONTROL-VARIOUS| ASSAY MONITORED WITH POS CONTROL-VARIOUS