BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192667 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02598
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2013-02599 AND 2032227-2013-02600.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS TREATED BY THE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE OF 42 MG/DL. THE CUSTOMER STATED THAT HE WAS USING THE SENSOR AND TRANSMITTER CORRECTLY, BUT WAS HAVING DIFFERENCES BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 70 MG/DL, BUT THE SENSOR GLUCOSE WAS 300 MG/DL. THE CUSTOMER CHECKED ANOTHER TIME, AND HIS BLOOD GLUCOSE WAS 40 MG/DL, BUT THE SENSOR GLUCOSE WAS 120 MG/DL. THE CUSTOMER TURNED THE SENSOR OFF AND ON, AND RECEIVED CAL ERROR AND BAD SENSOR ERRORS. THE CUSTOMER DID NOT KNOW WHAT CAUSED HIS LOW BLOOD GLUCOSE LEVELS, AND STATED THAT HE HAS LOW BLOOD GLUCOSE UNAWARENESS. THE CUSTOMER FELT THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292623 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization