BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4193034 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41780
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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 COMPROMISED FORCE SENSOR SYSTEM DURING BASIC OCCLUSION TEST DUE TO LOOSE AND OR PROTRUDED DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 33.0 MMOL/L. CUSTOMER'S FATHER STATED THAT THE CUSTOMER'S PUMP HAS DIED. CUSTOMER'S FATHER STATED THAT THE CUSTOMER WAS RUNNING A BIT HIGH WITH KETONES LAST NIGHT. WHILE THE CUSTOMER WAS ATTEMPTING TO CHANGE THE SET, THEY HAD AN ALARM. CUSTOMER WAS TREATED WITH A SPARE PUMP. CUSTOMER'S FATHER STATED THAT THE PUMP HAS ALREADY BEEN REMOVED. IT WAS ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CAUSE OF THE ALARM WAS EXPLAINED TO THE CUSTOMER'S FATHER. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672098 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAH

    Patients

    Seq Age Sex Outcome Treatment
    1