BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110042 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01910
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 STATED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM WITH CHEST PAIN, HIGH BLOOD PRESSURE AND BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS KEPT ELEVATING EVEN THOUGH SHE HAD GIVEN HERSELF INSULIN WITH THE INSULIN PUMP. NO TROUBLESHOOTING WAS DONE ON THE INSULIN PUMP AS THE CUSTOMER NO LONGER WANTS TO USE IT. THE CUSTOMER STATED THAT SHE IS TOO AFRAID TO USE IT, AND WILL BE SPEAKING WITH HER REPRESENTATIVE TO RETURN IT BACK TO US. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209923 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization