BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142241 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33363
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE WENT UP TO 500 MG/DL AND ON (B)(4) 2014, HE WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE OF 600 MG/DL AND DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH AN INTRAVENOUS INSULIN DRIP. HE WAS W EARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621900 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization