BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 6992613 · Received November 1, 2017

    Report

    Report Number
    3003442380-2017-00007
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    October 15, 2016
    Report Date
    November 1, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED INFUSION SET HAS BEEN RETURNED FOR TESTING. THE LOT REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCAP RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT 5130064 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS. THE CLAIMED FAILURE CANNOT BE CONFIRMED. AN INVESTIGATION HAS BEEN PERFORMED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND THE REFERENCE SAMPLES FROM THE SAME LOT NUMBER. 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). THE SPOUSE OF PATIENT REPORTED PATIENT (HIS WIFE) EXPERIENCED DIABETIC KETOACIDOSIS AND FALLING IN AND OUT OF CONSCIOUSNESS. DUE TO DIABETIC KETOACIDOSIS PATIENT VOMITED AND TORE HOLES IN ESOPHAGUS AND SPOUSE REPORTED DIABETIC KETOACIDOSIS CAUSED LACTACIDOSIS, HEART ATTACK , AND ORGAN FAILURE. THE PATIENT WAS ADMITTED IN ICU AT MOUNT SINAI MEDICAL CENTER WITH BLOOD GLUCOSE LEVEL ABOVE 1000 MG/DL FOR 2 DAYS, WAS UNCONSCIOUS FOR DAYS, AND PATIENTS MEMORY HAS BEEN AFFECTED DUE TO THE INCIDENT. THE PATIENT WAS WEARING THE PUMP AND INFUSION SET WHEN HOSPITALIZED AND UPON REMOVAL THE INFUSION SET CANNULA WAS FOUND BENT. PATIENT REPORTED WHEN TRYING TO GIVE BOLUS TO BRING DOWN GLUCOSE LEVEL THE INSULIN LEAKED OUT OF THE SITE. THE PATIENT DID NOT REPORT ANY ALARM INDICATING DISRUPTED FLOW CAUSING INSULIN NOT BEING DELIVERED TO THE SUBCUTANEOUS TISSUE. LEAKAGE AT SITE INDICATES THAT THE INFUSION SET HAD BECOME DISLODGED RESULTING IN THE BACKTUNNELING OF INSULIN. DURING WEAR THE INFUSION SETS SOFT CANNULA COULD BECOME SLIGHTLY BEND DUE TO MOVEMENT WITHOUT AFFECTING FLOW. THE DIABETIC EDUCATOR HAD SAID THAT IT WAS NOT PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772455 MIO INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-921 5130064

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R