BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190373 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82340
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 400MG/DL. THE CUSTOMER STATED THAT THE LAST INFUSION SET CHANGE PRIOR TO HER ADMISSION WAS ON (B)(6) 2011. THE CUSTOMER STATED THAT THE EVENTS LEADING TO HER HOSPITALIZATION WAS DEHYDRATION, NO DELIVERY ALARMS, HYPERVENTILATION, KETONES IN URINE, AND RAPID HEART RATE. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 176MG/DL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization