BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173682 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38325
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 398 MG/DL AT THE TIME OF HOSPITALIZATION. THE DOCTOR STATED THAT THE INSULIN PUMP HAD ALARMED MANY NO DELIVERY ALARMS, AND THE CUSTOMER NOTED THAT SHE PROBABLY WAS NOT ROTATING THE INSERTION SITES ENOUGH. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. THE CUSTOMER DID NOT WANT TO CHANGE THE INSERTION SITE AT THE TIME OF THE CALL. SHE COMPLAINED OF A STOMACH ACHE PRIOR TO HOSPITALIZATION AND REPORTED THAT SHE HAD CHANGED THE INSERTION SITE AND RESERVOIR BUT RECEIVED ANOTHER NO DELIVERY ALARM SHORTLY THEREAFTER. THE CALLER STATED THAT THE CUSTOMER WAS WEARING THE DEVICE AT THE TIME OF ADMITTANCE AND WAS TAKEN OFF OF THE INSULIN PUMP THERAPY ONCE ADMITTED. THE DOCTOR ADVISED THAT SHE WOULD TROUBLESHOOT THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654004 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization