BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3882447 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85915
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED AND LOOSE DRIVE SUPPORT DISK. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT RECEIVING AN ALARM ON HIS INSULIN PUMP DURING MANUAL PRIME PROCESS. WHILE TROUBLESHOOTING, CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. CURRENT BLOOD GLUCOSE LEVEL IS 130MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356934 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR