BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3073662 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01495
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. A SCRATCHED LCD WINDOW, CRACKED CASE AND CRACKED RESERVOIR TUBE LIP WAS ALSO NOTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP GAVE A BUTTON ERROR ALARM, BUT THE CUSTOMER COULD NOT CLEAR IT DUE TO UNRESPONSIVE BUTTONS. THE REPORTED BLOOD GLUCOSE READING WAS 6.0 MMOL/L. IT WAS STATED THAT THE CUSTOMER WAS SLEEPING AT THE TIME OF THE ALARM, AND MAY HAVE BEEN PRESSING ON THE BUTTONS, BUT ISN'T SURE. IT WAS ALSO STATED THAT THE TIME ON THE SCREEN WAS STUCK ON 12:21, AND HAD NOT CHANGED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE FROZEN DISPLAY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174413 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1