BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894865 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03373
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THE LAST THREE WEEKS. THE BLOOD GLUCOSE READING WAS 53 MG/DL. THE CUSTOMER STATED THAT SHE HAD BEEN TO THE DOCTOR AND ADJUSTED HER BASAL RATES. CONFIRMED THE CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. SHE REPORTED THAT HER BLOOD GLUCOSE LEVELS WERE HIGH THROUGHOUT THE DAY BEFORE, AND ON THE MORNING OF THE CALL IT DROPPED TO 39 MG/DL. SHE ADJUSTED THE RATES AGAIN AND REQUESTED ASSISTANCE WITH CHECKING THE FUNCTIONALITY OF THE INSULIN PUMP. UPON TROUBLESHOOT, OBSERVED THE PRIMING TECHNIQUE AND PROGRAMMING WERE ACCURATE. ALSO CONFIRMED THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. ADVISED CUSTOMER TO SPEAK WITH HER DOCTOR REGARDING LOW BLOOD GLUCOSE ISSUES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370188 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention