BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885220 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85972
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED THE DELIVERY ACCURACY TEST.

    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 STATED THAT SHE WAS HOSPITALIZED AROUND (B)(6) 2014 FOR HIGH BLOOD GLUCOSE LEVELS. SHE CANNOT REMEMBER THE EXACT BLOOD GLUCOSE LEVEL AT THE TIME OF HER HOSPITALIZATION. DURING THIS HOSPITALIZATION, THE CUSTOMER STATED THAT SHE WAS GIVEN INJECTIONS TO TREAT THE HIGH BLOOD GLUCOSE LEVELS. THE EVENT THAT LED UP TO THE HOSPITALIZATION WAS THAT SHE HAD A CYST THAT ERUPTED ON HER LEFT OVARY. ON (B)(6) 2014, THE CUSTOMER STATED THAT HER DOCTOR DECREASED HER BASAL RATES. AROUND (B)(6) 2014, SHE STARTED EXPERIENCING LOW BLOOD GLUCOSE LEVELS. HER BLOOD GLUCOSE LEVEL WAS 30 MG/DL. THE CUSTOMER TREATED WITH FOOD. DURING TROUBLESHOOTING, THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360517 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization