BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REA-TIME INSULIN INFUSION PUMP

    MDR report key: 4193879 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37097
    Event Type
    Injury
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE HIGH BLOOD GLUCOSE OF 525 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER REQUESTED TROUBLESHOOTING OF INSULIN PUMP TO VERIFY REASON FOR HIGH BLOOD GLUCOSE. DURING TROUBLESHOOTING, IT WAS FOUND THAT THERE WAS AIR BUBBLES IN RESERVOIR. TROUBLESHOOTING COULD NOT CONTINUE AS CUSTOMER DID NOT HAVE TUBING CLAMP. TUBING CLAMP WAS SENT TO CUSTOMER AND SHE WAS ADVISED TO CALL BACK TO CONTINUE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645619 PARADIGM REA-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention