BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAUNDICE METER JM-102

    MDR report key: 369675 · Received December 28, 2001

    Report

    Report Number
    2510954-2001-00027
    Event Type
    Malfunction
    Date Received
    December 28, 2001
    Date of Event
    December 5, 2001
    Report Date
    December 27, 2001
    Manufacturer
    HILL-ROM MANUFACTURING, , INC.
    Product Code
    MQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE JM102 INDICATES A VALUE OF 160UML FOR AN ICTEMIC 4TH INFANT, THE BLOOD TEST PERFORMED AT THE SAME TIME INDICATES A VALUE OF 300UML CONSEQUENTLY, THE PATHOLOGY REQUIRES A PHOTOTHERAPY FOR THIS INFANT WHO COULD HAVE INADVERTANTLY ON THE BASIS OF THE FIRST RESULT. THERE DOES NOT APPEAR TO BE ANY IMPACT ON THE CONDITION OF THIS INFANT AS A RESULT OF DELAYED PHOTOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58766 JAUNDICE METER JM-102 INFANT CARE MQM HILL-ROM MANUFACTURING, , INC. JM-102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other