BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110203 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-93390
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT WAS RECEIVED WITH INTERMITTENT BUTTON DUE TO MOISTURE DAMAGE AT KEYPAD TRACES. UNIT HAD CRACKED CASE AT DISPLAY WINDOW CORNERS AND SCRATCHED DISPLAY WINDOW. THE DRIVE SUPPORT WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED HIGH BLOOD GLUCOSE, DKA AND WAS HOSPITALIZED IN (B)(6) OF 2012. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. CALLER STATED THAT THE CUSTOMER JUMPED INTO THE POOL WITH THE INSULIN PUMP. CALLER STATED THAT THE INSULIN PUMP KEYPAD BUTTONS ARE STICKING AND THE DRIVE SUPPORT CAP IS LOOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211148 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization