BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM INFUSION SET

    MDR report key: 6321566 · Received February 10, 2017

    Report

    Report Number
    3003442380-2017-00003
    Event Type
    Death
    Date Received
    February 10, 2017
    Date of Event
    December 12, 2016
    Report Date
    February 10, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER (THE SON) PROVIDED FOLLOWING TWO LOT NUMBERS WHICH COULD HAVE BEEN AT USE AT TIME OF INCIDENT: LOT NUMBER 5144234 AND LOT NUMBER 5152580. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD # 5144234 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. THE BATCH RECORD # 5152580 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION AND TEST RESULTS THE CLAIMED FAILURE CAN NOT BE CONFIRMED. IF NEW INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. CLINICAL EVALUATION: THE SPOUSE REPORTED DEATH OF PATIENT DUE TO HEART FAILURE WHERE NOTHING INDICATES THIS WAS DUE TO SET MALFUNCTION OR USE ERROR. THE PATIENT GAVE A BOLUS IN THE EVENING AND PASSED AWAY DUE TO HEART FAILURE THE NEXT DAY. THE SPOUSE REPORTED PATIENT HAVING TROUBLE WITH INSULIN ABSORPTION RESULTING IN MORE FREQUENT CHANGES OF INFUSION SET THAN RECOMMEND IN THE IFU.

    Description of Event or Problem · 1

    (B)(4). SON OF MALE DIABETIC PATIENT ON PUMP THERAPY REPORTED PATIENT PASSED AWAY AT HOME ON (B)(6) 2016. DEATH WAS UNEXPECTED. THE OFFICIAL CAUSE OF DEATH WAS CORONARY ARTERIOSCLEROSIS ANGIOPLASTY, DIABETES MELLITUS TYPE 1, CORONARY BYPASS GRAFTING MULTIVESSEL, CEREBROVASCULAR DISEASE STATUS POST CEREBROVASCULAR ACCIDENT, CONGESTIVE HEART FAILURE. PATIENT WAS WEARING PUMP AND INFUSION SET AT TIME OF DEATH. UNABLE TO PROVIDE BLOOD GLUCOSE LEVEL AT TIME OF INCIDENT. LAST BOLUS ON PUMP 2.1U 2206 ON (B)(6) 2016 AND BLOOD GLUCOSE LEVEL WAS 326 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106620 QUICK-SET PARADIGM INFUSION SET QUICK-SET PCC FPA UNOMEDICAL A/S MMT-397 UNKNOWN - SEE COMMENT IN H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death