BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICKSERTER

    MDR report key: 3895425 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03369
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE MEDWATCH REPORT # 3004209178-2014-86045.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 337 MG/DL. THE CUSTOMER STATED THAT THE SERTER WAS GETTING STUCK, CAUSING HIM TO RESORT TO MANUAL INSERTIONS. THE INFUSION SETS WERE NOT MANUALLY INSERTED PROPERLY, AND THE CUSTOMER OBSERVED THE CANNULA BENDING ON TOP OF HIS SKIN. HE REPORTED EXPERIENCE OF OCCLUSIONS AND NO DELIVERY OF INSULIN. THE CUSTOMER ALSO STATED THAT HIS BLOOD GLUCOSE LEVELS WERE HIGH BECAUSE HE HAD TO TAKE MANUAL INJECTIONS AND DID NOT KNOW WHETHER HE WAS COUNTING CARBOHYDRATES CORRECTLY. ADVISED THE CUSTOMER THAT THE SERTER WOULD BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370013 PARADIGM QUICKSERTER KZH KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization