BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2802019 · Received October 23, 2012

    Report

    Report Number
    2032227-2012-07515
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 490 MG/DL. THE CUSTOMER STATED THAT SHE EXPERIENCED VOMITING, LOW BLOOD PRESSURE, HIGH BLOOD GLUCOSE LEVELS AND BURNING IN HER MUSCLES. THE CUSTOMER STATED THAT THERE WAS A DEATH IN HER FAMILY ONE WEEK EARLIER AS WELL. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED BACK IN (B)(6) DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE HAD A SEIZURE AND BLACKED OUT PRIOR TO THE EVENT. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING THAT EVENT SINCE IT WAS SO LONG AGO. THE CUSTOMER ONLY REMEMBERED THAT SHE OVER BOLUSED AND ALL OF THE INSULIN JUST CAUGHT UP TO HER. THE CUSTOMER DECLINED TROUBLESHOOTING AS SHE STATED SHE HAD ALREADY TROUBLESHOT WITH HER INSULIN PUMP TRAINER, AND FOUND THAT THE INSULIN PUMP WAS WORKING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization