BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3023963 · Received March 27, 2013

    Report

    Report Number
    2032227-2013-01166
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO BLOOD GLUCOSE LEVELS AS LOW AS 30 MG/DL. THE CUSTOMER STATED THAT HE HAD A BLOOD GLUCOSE OF 141 MG/DL TWO HOURS PRIOR TO THE EVENT. THE CUSTOMER STATED THAT HE ATE BREAKFAST, AND HE MAY HAVE ENTERED MORE CARBOHYDRATES INTO THE BOLUS WIZARD THAN WHAT HE ACTUALLY CONSUMED. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE SELF TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125866 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization