BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2870058 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07996
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    UP ARROW BUTTON UNRESPONSIVE DUE TO CORRODED KEYPAD TRACES. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED BECAUSE, SHE FELT THAT THE NO DELIVERY ALARM WAS NOT WORKING. ADVISED THE CUSTOMER THAT TROUBLESHOOTING COULD BE CONDUCTED TO TEST THE ALARM'S FUNCTION, BUT SHE DIDN'T HAVE THE TUBING CLAMP. THE TUBING CLAMP WAS SHIPPED. THE CUSTOMER LATER CALLED TO REPORT UNRESPONSIVE BUTTONS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR