BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3083656 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92878
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CRACKED DISPLAY WINDOW, CRACKED RESERVOIR WINDOW AND CRACKED RESERVOIR TUBE LIP NOTED DURING VISUAL INSPECTION. UNABLE TO PRIME DURING PRIME ALARM TEST. THE INSULIN PUMP ALARMED DURING BASIC OCCLUSION DUE TO LOOSE DRIVE SUPPORT DISK.

    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 IS REPORTED THAT INSULIN PUMP ALARMED PRIME ALARM AND INSULIN SQUIRTED OUT DURING MANUAL PRIME. CUSTOMER WAS DISCONNECTED DURING PRIME. LEAVING PRIME NOT POSSIBLE. INSULIN PUMP NOT DROPPED, BUMPED OR EXPOSED TO WATER. DRIVE SUPPORT DISK IS DAMAGED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185310 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1