BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2791860 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07412
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 560MG/DL. THE CALLER STATED THAT HER HUSBAND HEARD BANGING HER HEAD ON THE WALL WHEN SHE WAS HAVING THE STROKE. THEN HE TREATED WITH AN INSULIN PEN AND ATTEMPTED ALSO TO GIVE HER ORANGE JUICE, BUT SHE COULD NOT TAKE IT, AND THE PARAMEDICS WERE CALLED. THE CALLER IS UNSURE IF SHE WAS WEARING THE INSULIN PUMP. SHE WAS TOLD THAT SHE HAD BAD STROKE AND SEIZURE. HER HEART BEATING WAS VERY FAST, WHICH CAUSED TO CLOG HER VEIN GOING TO HER BRAIN. THE CALLER STATED THAT SHE WAS NOT FEELING WELL ALL DAY AND HER GLUCOSE LEVEL WAS LOW MANY TIMES. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. INSTRUCTED TO REMOVE THE CANNULA AND IT WAS NOT. ADVISED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. SUGGESTED TO CHANGE THE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization