BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141791 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33659
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    April 15, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. DETACHED END CAP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S MOTHER WAS REWINDING THE INSULIN PUMP AND SHE NOTICED THE BOTTOM END COMING OFF. BLOOD GLUCOSE VALUE IS 68 MG/DL. IT WAS STATED THAT THE PHYSICAL DAMAGE TO THE INSULIN PUMP IS END CAP CAME OFF AND WIRES ARE SHOWING. CUSTOMER WAS NOT AWARE OF HOW THE DAMAGE OCCURRED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621564 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR