BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWBORN SCREENING BLOOD-SPOT COLLECTION DEVICE

    MDR report key: 1852869 · Received September 29, 2010

    Report

    Report Number
    MW5017623
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    NAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE (B)(6) 2010, THE LABORATORIES ADMINISTRATION OF THE (B)(6) STATE DEPT OF HEALTH AND MENTAL HYGIENE HAS IDENTIFIED APPROXIMATELY 170 NEWBORN SCREENING TEST RESULTS FOR BIOTINIDASE DEFICIENCY WITH NO BIOTINIDASE ACTIVITY. THERE IS A POSSIBILITY THAT THESE RESULTS ARE ASSOCIATED WITH LOT W092 OF NEWBORN SCREENING BLOOD-SPOT FILTER PAPER FORMS -SPECIMEN COLLECTION DEVICES- MFG BY GE HEALTHCARE. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SCREENING NEWBORNS FOR HEREDITARY DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWBORN SCREENING BLOOD-SPOT COLLECTION DEVICE NAK GE HEALTHCARE W092

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability