BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190281 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82236
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 700MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING, HE DECREASED TAKING FLUIDS AND FOOD FOR TWENTY FOUR HOURS, AND HIS BLOOD GLUCOSE SPIKED. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH AN INSULIN DRIP WHEN HE ARRIVED TO THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER WAS RECONNECTED TO THE INSULIN PUMP AND HIS BLOOD GLUCOSE STARTED TO CLIMB. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 440MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR (B)(6). TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. IT WAS STATED THAT THE DOCTOR WILL BE MAKING ADJUSTMENTS TO BOLUS WIZARD AND BASALS SETTINGS BECAUSE THEY APPEAR TO BE LOWER THAN WHAT THE CUSTOMER NEEDED. 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-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization (B)(4) INFUSION SET, MMT-381| SILHOUETTE 23"