BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2810336 · Received October 31, 2012

    Report

    Report Number
    2032227-2012-07598
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 27, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 450 MG/DL. THE CUSTOMER STATED THAT SHE WAS VOMITING AND WAS HAVING TROUBLE BREATHING. THE CUSTOMER ALSO STATED THAT SHE EXPERIENCED DIABETIC KETOACIDOSIS ON (B)(6) 2012. THE CUSTOMER STATED THAT SHE CALLED HER HCP. THE CUSTOMER STATED THAT HER HCP HAS HER CHANGE HER BASAL RATES EVERY TWO WEEKS TO ADJUST FOR LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS FOUND TO BE PROGRAMMED CORRECTLY. FOUND LOW BATTERY AND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE A TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT SHE WOULD CALL BACK TO CONTINUE WITH THE TROUBLESHOOTING.

    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 29 YR Hospitalization