BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5031838 · Received August 26, 2015

    Report

    Report Number
    2032227-2015-35279
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAS MINOR SCRATCHES ON THE LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM AND THE KEYPAD WAS UNRESPONSIVE. THE CUSTOMER'S HUSBAND REPORTED THAT THE INSULIN PUMP WAS KEPT IN THE CUSTOMER'S BRA. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 164 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565863 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1