BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 3429544 · Received October 18, 2013

    Report

    Report Number
    8021545-2013-00005
    Event Type
    Death
    Date Received
    October 18, 2013
    Date of Event
    February 21, 2011
    Report Date
    October 18, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE OF DEATH WAS REPORTED AS A RESULT A DIABETIC SEIZER WHEN HIS BLOOD SUGAR FELL. AT THIS TIME NO USED DEVICES WILL BE RETURNED TO UNOMEDICAL A/S FOR INVESTIGATION. TESTS OF THE CLAIMED FAILURE CANNOT BE CONFIRMED. IF RELEVANT INFO BECOMES AVAILABLE THE COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. USED DEVICE: NO USED DEVICES WERE RETURNED FOR INVESTIGATION. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK, STATIC PULL, CONNECTOR AND NEEDLE. ALL TESTS RESULTS WERE WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535850 SILHOUETTE PARADIGM COMFORT PCC FPA UNOMEDICAL A/S MMT-377 612634

    Patients

    Seq Age Sex Outcome Treatment
    1 Death