BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3243690 · Received July 23, 2013

    Report

    Report Number
    2032227-2013-03103
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. A CRACKED RESERVOIR TUBE LIP AND SCRATCHED DISPLAY WINDOW WAS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 770 MG/DL. THE CUSTOMER STATED THAT HE WAS SICK TO HIS STOMACH, SWEATING, VERY THIRSTY AND DIZZY. THE CUSTOMER HAD PREVIOUSLY CALLED TO REPORT A PROBLEM WITH THE BUTTONS. DUE TO THE BUTTON PROBLEMS, HE WAS UNABLE TO CONTINUE USING THE DEVICE. BECAUSE OF THIS, HIS BLOOD GLUCOSE ELEVATED, AND HE ENDED UP IN THE HOSPITAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343389 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization