BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4181496 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39587
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW WHY SHE PASSED OUT. CUSTOMER'S HUSBAND WANTS TO KNOW THE AMOUNT OF INSULIN GIVEN TO HIS WIFE. CUSTOMER WAS AWARE THAT THE PUMP WAS FUNCTIONING AND TO CALL THE HELPLINE IF NEEDED. CUSTOMER'S HUSBAND STATED THAT HIS WIFE'S MOST RECENT BLOOD GLUCOSE LEVEL WAS 193 MG/DL. CUSTOMER'S HUSBAND STATED THAT HER HEALTH CARE PROFESSIONAL IS AWARE OF HER LOW BLOOD GLUCOSE LEVEL AND ARE LOOKING INTO IT. CUSTOMER'S HUSBAND STATED THAT SHE HAD A BLOOD GLUCOSE LEVEL OF 440 MG/DL AND ACCIDENTALLY GAVE HERSELF TOO MUCH INSULIN. CUSTOMER'S HUSBAND ALSO STATED THAT THE CUSTOMER'S HEALTH CARE PROFESSIONAL WAS CONTACTED. HOWEVER, HE DOES NOT KNOW WHAT TIME SHE PASSED OUT. CUSTOMER WAS CONNECTED TO THE PUMP WHEN SHE PASSED OUT BUT DOES NOT KNOW HER BLOOD GLUCOSE LEVEL. CUSTOMER'S HUSBAND DECLINED TROUBLESHOOTING. A FUNCTIONAL CHECK WAS RUN ON THE PUMP AND EVERYTHING CAME BACK POSITIVE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660931 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR