BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123619 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29686
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED HIGH BLOOD GLUCOSE DUE TO HAVING PROBLEMS WITH HER INFUSION SETS. CUSTOMER DISCONNECTED AT THE QUICK RELEASE AND THREW A BOLUS INTO THE AIR OF 1.0 INSULIN UNIT WHICH DID DELIVER. CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND CANNULA WAS STRAIGHT. CUSTOMER THEN WENT TO BED AND WOKE UP IN THE MORNING WITH BLOOD GLUCOSE READINGS OF 19 MMOL/L. CUSTOMER REPEATED THROWING A BOLUS INTO THE AIR SUCCESSFULLY. CUSTOMER THOUGHT THERE COULD BE AN AIR BUBBLE IN THE TUBING AND CHANGED THE INFUSION SET AGAIN; BUT NOW THE INSULIN DID NOT EXIT THE TUBING. CUSTOMER DISCONNECTED THE INSULIN PUMP AND REVERTED TO MANUAL INSULIN INJECTIONS. CUSTOMER DID A NEW SET CHANGE AND RECEIVED A NO DELIVERY ALARM DURING PRIME. LAST BLOOD GLUCOSE VALUE IS 20 MG/DL; TREATED WITH THE INSULIN PUMP BUT IT DID NOT GO DOWN WILL GIVE A MANUAL INJECTION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602309 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1