BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4151594 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34670
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S SENSOR INSULIN PUMP DISPLAYED A BUTTON ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 100MG/DL. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633325 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR