BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTODELFIA NEONATAL 17A-OH-PROGESTERONE

    MDR report key: 793835 · Received December 8, 2006

    Report

    Report Number
    8043909-2006-00001
    Event Type
    Other
    Date Received
    December 8, 2006
    Date of Event
    November 8, 2006
    Report Date
    December 8, 2006
    Manufacturer
    WALLAC OY
    Product Code
    JLX
    PMA / PMN Number
    K042425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATIONS OF THE KIT LOT CONCERNED HAS SHOWN THAT THE PRODUCT IS PERFORMING ACCORDING TO ITS SPECIFICATIONS. THEREFORE, NO RECALL NEED HAS BEEN IDENTIFIED. THE POSSIBLE ROOT CAUSE FOR THE NEGATIVE RESULT IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE EVENT IS ASSOCIATED WITH THE USE OF THE AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT, WHICH IS INTENDED FOR THE QUANTITATIVE DETERMINATION OF HUMAN 17A-OH-PROGESTERONE IN BLOOD SPECIMENS DRIED ON FILTER PAPER AS AN AID IN SCREENING NEWBORNS FOR CONGENITAL ADRENAL HYPERPLASIA (CAH) USING THE 1235 AUTODELFIA AUTOMATIC IMMUNOASSAY SYSTEM. THE LAB CALLED 11/8/06 ABOUT THAT THEY HAD FOUND OUT THAT THEY HAD APPARENTLY MISSED A BABY IN THE SCREENING PROGRAM. THE BABY BECAME SICK AND WAS AT THE HOSP IN LATE OCTOBER. THE BABY IS REPORTED TO BE RECOVERING WELL. THE ORIGINAL SAMPLE TESTED IN 08/06 HAD BEEN REPORTED AS NEGATIVE, BUT WHEN RETESTED IN 11/06, IT WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE FLUOROIMMUNOASSAY/17-OH-PROGESTERONE JLX WALLAC OY B015-112 351 837

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization