BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183167 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40084
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER DOES NOT THINK THE PUMP IS DELIVERING INSULIN LIKE IT SHOULD. CUSTOMER HAS BEEN RUNNING HIGH FOR THE PAST 5 YEARS. CUSTOMER STATED THAT HE HAS NOT CHANGED HIS DIET. CUSTOMER STATED THAT HE ADJUSTED HIS BOLUS AND SENSITIVITY. CUSTOMER STATED THAT HE TOOK 87 UNITS ON SATURDAY AND HAD A KIDNEY TRANSPLANT 20 YEARS AGO. CUSTOMER'S KIDNEY IS "SHOT". CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 464 MG/DL. CUSTOMER CHANGED THE SET AND HAS TRIED TO CONTACT HIS HEALTH CARE PROFESSIONAL. CUSTOMER HAS TREATED FOR HIS HIGH BLOOD GLUCOSE LEVELS. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN DID EXIT. PUMP SETTINGS AND HISTORY ARE CORRECT. A LOW RESERVOIR ALARM AND LOW BATTERY ALARM WERE FOUND IN THE ALARM HISTORY. CUSTOMER DOES NOT HAVE A TUBING CLAMP. CUSTOMER WILL BE SENT A TUBING CLAMP AND WILL NEED TO CALL BACK TO CONTINUE TROUBLESHOOTING. CUSTOMER STATED THAT THE CANNULA IS NOT OCCLUDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660323 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR