BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO INFUSION SET

    MDR report key: 6172829 · Received December 14, 2016

    Report

    Report Number
    3003442380-2016-00019
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 14, 2016
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 14-DEC-2016: 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: BASED ON THE INFORMATION FROM PATIENT, AN INFUSION SET HAS BEEN A FACTOR IN A SERIOUS INJURY DUE TO A MISTAKE MADE BY THE PATIENT USING THE DEVICE (USE ERROR). AS PART OF TREATMENT REGIMEN, DIABETIC PATIENTS ARE TO INSPECT INFUSION SITE/INFUSION SET AND MEASURE BLOOD GLUCOSE LEVEL REGULARLY TO ENSURE ADEQUATE TREATMENT OF THEIR DIABETES. THE PATIENT REPORTED MULTIPLE SERIOUS SERIES OF EVENTS: MIGRAINES, URINARY TRACT INFECTION (CAUSED PATIENT TO HAVE SEPSIS), AND ELEVATED BLOOD GLUCOSE LEVEL, LEADING TO DIABETIC COMA (UNCONSCIOUSNESS) DUE TO THE CANNULA DID NEVER PENETRATE THE SKIN (WHEN INSERTION OF INFUSION SET. PATIENT NOTICED INTRODUCER NEEDLE WAS BENT UPON INSERTION). THE PATIENT WAS ABLE TO CALL FOR MEDICAL ASSISTANCE AND WAS TREATED AT HOSPITAL: INSULIN, FLUIDS, ANTIBIOTICS AND PAIN MEDICATION. THERE IS NO INFORMATION OF ANY CLINICAL CONSEQUENCES DUE TO THESE EVENTS.

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) 2016 A FEMALE DIABETIC PATIENT EXPERIENCED HIGH BLOOD GLUCOSE, DIABETIC KETOACIDOSIS (DKA) AND DIABETIC COMA AND WAS HOSPITALIZED. THE BLOOD GLUCOSE WAS OVER 600 MG/DL AT TIME OF HOSPITALIZATION. PATIENT WAS WEARING PUMP AT TIME OF HOSPITALIZATION. NAME OF HOSPITAL: (B)(6) GENERAL HOSPITAL. PATIENTS HUSBAND TOLD HER THAT MORNING SHE FILLED THE RESERVOIR FOR HER PUMP. WHEN SHE INSERTED IT THE CANNULA DID NOT GO INTO HER SKIN. IT BENT AND SHE PULLED OUT THE NEEDLE BUT THE CANNULA DID NOT GO IN SO SHE WAS NOT GETTING ANY INSULIN ALL DAY WHICH ALSO CAUSED BGS TO GO UP. PATIENT REMEMBERS SHE HAD NOT BEEN FEELING GOOD AT ALL - WAS HAVING SERIES OF EVENTS: MIGRAINES, URINARY TRACT INFECTION (CAUSED PATIENT TO HAVE SEPSIS), AND ELEVATED BLOOD GLUCOSE LEVEL, LEADING TO DIABETIC COMA (UNCONSCIOUSNESS) DUE TO THE CANNULA DID NEVER PENETRATE THE SKIN (WHEN INSERTION OF INFUSION SET. PATIENT NOTICED INTRODUCER NEEDLE WAS BENT UPON INSERTION). THE PATIENT WAS ABLE TO CALL FOR MEDICAL ASSISTANCE AND WAS TREATED AT HOSPITAL: INSULIN, FLUIDS, ANTIBIOTICS AND PAIN MEDICATION. CAUSE OF HOSPITALIZATION PER HCP: HIGH BLOOD GLUCOSE, DIABETIC KETOACIDOSIS (DKA) AND DIABETIC COMA. THERE IS NO INFORMATION OF ANY CLINICAL CONSEQUENCES DUE TO THESE EVENTS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824128 MIO INFUSION SET MIO INFUSION SET FPA UNOMEDICAL A/S MMT-975 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L