BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM INFUSION SET

    MDR report key: 6363767 · Received February 28, 2017

    Report

    Report Number
    3003442380-2017-00005
    Event Type
    Death
    Date Received
    February 28, 2017
    Date of Event
    December 3, 2016
    Report Date
    February 28, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    28-FEB-2017: NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFORMATION WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WERE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. THIS CASE HAS BEEN CLOSED DUE TO MISSING INFORMATION. NO RELEVANT TESTING COULD BE PERFORMED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH RECORD REVIEW OR TESTING OF RETAINED SAMPLES COULD BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE CASE WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. CLINICAL EVALUATION: THE SPOUSE OF PATIENT INFORMED THAT PATIENT HAD PASSED AWAY. PATIENT WENT TO BED, AND DID NOT WAKE UP. THERE ARE NO INFORMATION OF PATIENTS BLOOD GLUCOSE LEVEL AT TIME OF DEATH, NO CLINICAL SYMPTOMS UP TO DEATH WAS NOTICED AND THE SPOUSE DID NOT REPORT ANY INDICATIONS OF PUMP OR INFUSION SET MALFUNCTION. NO USED INFUSION SET WAS RETURNED FOR TESTING AND DUE TO NO LOT NUMBER REPORTED NO REFERENCE SAMPLES WERE TESTED. IF NEW INFORMATION BECOMES AVAILABLE THIS CASE WILL BE REEVALUATED.

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) 2016 A FEMALE DIABETIC PATIENT ON PUMP THERAPY PASSED AWAY AT HOME. THE SPOUSE OF THE PATIENT REPORTED THE PATIENT WENT TO BED AND DID NOT WAKE UP. THE PATIENT WAS WEARING PUMP AT TIME OF DEATH. THE BLOOD GLUCOSE LEVEL AT TIME OF DEATH IS UNKNOWN. OFFICIAL CAUSE OF DEATH IS DIABETES MELLITUS TYPE 1. NO OTHER COMPLICATIONS HAVE BEEN REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148498 QUICK-SET PARADIGM INFUSION SET QUICK- SET INFUSION SET FPA UNOMEDICAL A/S MMT-399 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death