BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3231199 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02953
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2012
    Report Date
    July 11, 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

    A PHONE CALL WAS MADE TO THE CUSTOMER IN ORDER TO FOLLOW UP ON A CALL SHE HAD MADE PREVIOUSLY REGARDING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT ANSWER, BUT SENT AN EMAIL STATING SHE WAS HOSPITALIZED THREE TIMES IN (B)(6) DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER ALSO MENTIONED A HOSPITALIZED ON (B)(6) 2012 FOR ABDOMINAL PAIN. DURING THAT HOSPITALIZATION, SHE EXPERIENCED HYPOGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331434 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization