BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4192621 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41492
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    CUSTOMER REPORTS TO HAVE BEEN HOSPITALIZED ON (B)(6) 2014 WITH BLOOD GLUCOSE OF 557 MG/DL. CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND POSSIBLY A MILD HEART ATTACK. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF CALL WAS 603 MG/DL. CUSTOMER WAS TREATED WITH INSULIN DRIP. TROUBLE SHOOTING WAS PERFORMED WITH CUSTOMER'S WIFE, BUT COULD NOT BE COMPLETED DUE TO CUSTOMER STILL BEING IN THE HOSPITAL AND BEING ATTENDED BY HEALTH CARE PROFESSIONAL. CUSTOMER WILL CALL HELPLINE ONCE HE IS OUT OF THE HOSPITAL AND ABLE TO LOCATE TUBING CLAMP IN ORDER TO COMPLETE TROUBLESHOOTING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671308 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization