BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3120991 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02002
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 25, 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 CALLED TO REPORT NO DELIVERY ALARMS. THE CUSTOMER ALSO STATED THAT HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS TWICE. ONCE IN (B)(6), AND ONCE IN (B)(6). BOTH TIMES WITH BLOOD GLUCOSE LEVELS OF 400 MG/DL. THE CUSTOMER STATED HE HAD BEEN SICK A LOT THIS WINTER, AND HAD THE FLU BOTH TIMES. THE CUSTOMER STATED THAT HE MAY BE INSERTING INTO SCAR TISSUE AS HE'S BEEN DIABETIC FOR A VERY LONG TIME. THE CUSTOMER DECLINED TROUBLESHOOTING AT THIS TIME. ADVISED TO CALL BACK AS NEEDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222581 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization