BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2965209 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-91083
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 HAVING DIFFICULTIES WITH HER INSULIN PUMP, AND HER BLOOD GLUCOSE READING WAS 533MG/DL. THE CALLER STATED THAT SHE SAW THE DOCTOR IN THE CLINIC, AND THE DOCTOR ASSISTED HER CHANGING THE INFUSION SET AND DELIVERING A BOLUS OF 10.0 UNITS. THE CUSTOMER STATED THAT SHE CHANGED THE SITE AND WENT TO BED. WHILE LYING DOWN SHE STARTED TO FEEL NAUSEOUS. TROUBLESHOOTING WAS DECLINED AS CUSTOMER STARTED HAVING DIFFICULTIES TO SEE THE SCREEN ON THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66483 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 55 YR Hospitalization