BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3041697 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92429
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    June 1, 2012
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED IN JUNE 2012 WITH HIGH BLOOD GLUCOSE OF 500 TO 800MG/DL, AND SHE WAS CONSTANTLY VOMITING. THE CALLER MENTIONED THAT THE CANNULA WAS BENT, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE CUSTOMER STATED THAT SHE DID NOT REPORT THE INCIDENT BEFORE. THE CALLER FEELS THAT THE INSULIN PUMP IS NOT FUNCTIONING PROPERLY, AND TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER IS AT WORK AND DOES NOT EXTRA SUPPLIES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143269 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization