BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK7100

    MDR report key: 102772 · Received July 3, 1997

    Report

    Report Number
    8010047-1997-00021
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    June 2, 1997
    Report Date
    July 3, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO., LTD SAN-EI BUILDING
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED MULTIPLE MISTYPES INVOLVING TWO ANALYZERS TO CO'S FIELD SERVICE ENGINEER. THE NATURE OF THESE MISTYPES WAS UNCLEAR AT THE TIME OF THE INITIAL REPORT; HOWEVER, A LOOSE ELECTRICAL CONNECTION ON ONE OF THE INSTRUMENTS MAY HAVE BEEN ASSOCIATED WITH THE REPORTED EVENT. ADDL DATA WAS REQUESTED FROM THE ACCOUNT IN ORDER TO AID THE INVESTIGATION. THE ACCOUNT WAS UNABLE TO PROVIDE ALL THE NECESSARY INFO; THEREFORE, THE CAUSE OF THE MISTYPES CAN NOT BE ATTRIBUTED TO A SINGLE CAUSATIVE FACTOR FROM THE INFORMATION PROVIDED. THOUGH THE ELECTRICAL PROBLEM MAY HAVE CONTRIBUTED TO 3 OF THESE MISTYPES, OTHER FACTORS CANNOT BE ELIMINATED FROM CONSIDERATION SINCE THESE MISTYPES INVOLVED TWO ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7100 AUTOMATED BLOOD GROUPING ANALYZER KSZ THE OLYMPUS OPTICAL CO., LTD SAN-EI BUILDING PK7100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other