BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4143398 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30198
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM ON HER INSULIN PUMP DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE IS 422 MG/DL. SHE TREATED WITH A MANUAL INJECTION. CUSTOMER DISCONNECTED FROM THE DEVICE AND RAN A FIXED PRIME, BUT THE DEVICE ALARMED NO DELIVERY. CUSTOMER TRIED MANUALLY PUSHING INSULIN THROUGH THE TUBING, BUT THERE WAS GREATER THAN NORMAL RESISTANCE. CUSTOMER WAS ADVISED THE ALARM WAS CAUSED BY A CONNECTION ISSUE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603429 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention