BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM INFUSION SET

    MDR report key: 7107773 · Received December 12, 2017

    Report

    Report Number
    3003442380-2017-00026
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    July 29, 2017
    Report Date
    December 12, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006331
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED FAILURE CANNOT BE CONFIRMED. AN INVESTIGATION HAS BEEN PERFORMED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION. NO USED SAMPLES RETURNED FOR INVESTIGATION NOR ANY LOT NUMBER PROVIDED. NO RELEVANT TESTING COULD BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    (B)(4). THIS INCIDENT OCCURED IN (B)(6). ON (B)(6) 2017 A DIABETIC MALE PATIENT ON PUMP THERAPY EXPERIENCED LOW BLOOD GLUCOSE. HE DROVE TO A PARTY (NO ALCOHOL, NO DRUGS CONSUMPTION) AND PASSED OUT. AFTER HE CAME TO HIMSELF, HE CALLED HIS BROTHER (RESCUE ASSISTANT) WHO ARRIVED SOON AFTER AND CALLED THE AMBULANCE. THE PATIENT WAS ADMITTED TO HOSPITAL ((B)(6)). BLOOD GLUCOSE AT TIME OF INCIDENT IS UNKNOWN. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2017. PATIENT SUFFERED BLOW-OUT FRACTURE. THE FATHER OF THE PATIENT REPORTED THE INCIDENT AND ASSUMED THAT THE EVENT WAS CAUSED BY THE QUICK SET INFUSION SET.. HE EXCLUDED THE POSSIBILITY THAT THERE WAS MOISTURE BETWEEN THE RESERVOIR AND THE P-CAP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888497 QUICK-SET PARADIGM INFUSION SET QUICK-SET PARADIGM FPA UNOMEDICAL A/S MMT-399 UNKNOWN 05705244006331

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L