BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    MDR report key: 6405717 · Received March 15, 2017

    Report

    Report Number
    1056600-2017-00031
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    March 15, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT AND MASTER LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    EVENT 1 OF 2. ORTHO CARE RECEIVED DATA FROM THE CUSTOMER IN SUPPORT OF A PREVIOUSLY DOCUMENTED CONCERN AGAINST THE ACCOUNTS ((B)(4)-FALSE NEGATIVE WITH ANTI-IGG CARD ON VISION) AND (B)(4) (PROVUE GEL CAMERA MISREAD). WITHIN THAT DATA, FALSE NEGATIVE RESULTS WERE IDENTIFIED WITH A PATIENT KNOWN TO CONTAIN ANTI-E BY THE MANUAL GEL METHOD. THIS HAPPENED DURING THE CUSTOMER'S VALIDATION TESTING BETWEEN THE VISION, PROVUE AND MANUAL GEL TESTING. ISSUE STARTED ON: 01-23-2017, FREQUENCY: X2. (B)(6). ORTHO CARE WAS ABLE TO CONFIRM THAT NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS REPORTED CONCERN. CONCERN ASSOCIATED TO VALIDATION TESTING. NO OTHER SPECIFIC DETAILS PROVIDED BY THE CUSTOMER. CUSTOMER REQUIRES NO ADDITIONAL FOLLOW UP. CUSTOMER HAS AGREED TO CONTACT ORTHO CARE IF ANY ADDITIONAL QUESTIONS OR CONCERNS ARISE REGARDING THIS REPORTED EVENT. CUSTOMER SATISFIED WITH DISCUSSION. ORTHO CARE RECEIVED THE DATA REFLECTING THE REPORTED CONCERN VIA MAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188035 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST KSZ MICROTYPING SYSTEMS 041416001-03

    Patients

    Seq Age Sex Outcome Treatment
    1