BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233829 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48572
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER HAS BEEN OFF THE PUMP FOR 3 MONTHS. CUSTOMER IS NOT USING THE PUMP. IT WAS EXPLAINED THAT DURING SEATING, THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. CUSTOMER STATED THEY ARE UNSURE IF THE DRIVE SUPPORT CAP IS DAMAGED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP. CUSTOMER ASKED IF HE COULD BUY A PUMP ON THE BLACK MARKET. CUSTOMER WAS ADVISED THAT IT WAS NOT RECOMMENDED AS IT IS ILLEGAL AND MAY NOT BE SUPPORTED. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER DOES NOT KNOW WHERE THE OLD PUMP IS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714159 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR