BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3122904 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-01891
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED TWO TIMES ON (B)(64) 2013 AND (B)(6) 2013 AND HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE BOTH OF THE TIMES. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS AROUND 37 MG/DL BOTH OF TIMES WHEN PARAMEDICS ARRIVED. CUSTOMER STATED THAT SHE HAD SEIZURES AND WAS FOUND UNCONSCIOUS AND SPOUSE CALLED THE PARAMEDICS. CUSTOMER STATED THAT HER INSULIN PUMP DELIVERED ALL THE INSULIN IN THE RESERVOIR WHEN IT WAS IN SUSPEND MODE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224902 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization