BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3130796 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94086
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 RECEIVED WITH PRIME ALARMS DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAS ALARMED PRIME ALARM. CUSTOMER'S BLOOD GLUCOSE READING IS 356 MG/DL. INSULIN SQUIRTS OUT DURING THE MANUAL PRIME PROCESS. THE DRIVE SUPPORT CAP IS PROTRUDED. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232231 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR