BEUDAMED
    FDA Adverse Event Other Summary report: N

    BODY FLUID COLLECTION PAPER '903'

    MDR report key: 1880530 · Received October 19, 2010

    Report

    Report Number
    1281317-2010-00004
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    GE HEALTHCARE BI-SCIENCES CORP
    Product Code
    JKA
    PMA / PMN Number
    K932661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INDICATED AS A BLOOD SPECIMEN RECEPTACLE. THE BLOOD IS TRANSPORTED TO A LABORATORY AS DRIED BLOOD SPOTS. NO OTHER INDICATIONS OR CLAIMS ARE SUPPORTED. THE COMPLAINT DESCRIBED BY THE CUSTOMER IS OF LOW ASSAYS OF BIOTINIDASE FROM BLOOD SAMPLES APPLIED TO (B)(4). THE CUSTOMER ALLEGES THAT THE LOW ASSAY IS CAUSED BY THE (B)(4) LOT W092. INVESTIGATION IN PROCESS. A FOLLOW UP REPORT WILL BE SUPPLIED IN 30 DAYS, ON OR BEFORE (B)(6) 2010.

    Description of Event or Problem · 1

    THE DEVICE IS INDICATED FOR USE BY HEALTH CARE PROFESSIONALS IN THE COLLECTION AND TRANSPORT TO A CLINICAL LABORATORY OF NEONATE BLOOD AS DRIED BLOOD SPOTS. THE NEONATE BLOOD IS TESTED TO SCREEN THE INFANT FOR CONGENITAL ABNORMALITIES OF METABOLISM AND OTHER CONDITIONS. THE DEVICE IS PRESENTED AS JOINED PARTS WHICH CONSTITUTE THE TOTAL DEVICE PRESENTATION; FORMS PROVIDING THE INFANTS DEMOGRAPHIC DETAILS, AND THE (B)(4) TO WHICH CAPILLARY BLOOD SPOTS ARE APPLIED. THE DEVICE IS INDICATED AS A BLOOD SPECIMEN RECEPTACLE. THE BLOOD IS TRANSPORTED TO A LABORATORY AS DRIED BLOOD SPOTS. NO OTHER INDICATIONS OR CLAIMS ARE SUPPORTED. THE COMPLAINT DESCRIBED BY THE CUSTOMER IS OF LOW ASSAYS OF BIOTINIDASE FROM BLOOD SAMPLES APPLIED TO (B)(4). THE CUSTOMER ALLEGES THAT THE LOW ASSAY IS CAUSED BY THE (B)(4) LOT W092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODY FLUID COLLECTION PAPER '903' JKA GE HEALTHCARE BI-SCIENCES CORP 10534536 W092/6871110

    Patients

    Seq Age Sex Outcome Treatment
    1