BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240511 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49727
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-49785.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE EVENT AND THAT THE INSULIN PUMP SEEMED TO BE OVER-BOLUSING. THE BLOOD GLUCOSE READING WAS 42 MG/DL, AND THE CUSTOMER ATE 40 UNITS OF CARBS, BRINGING THE READING UP TO 127 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP RECOMMENDED A BOLUS AMOUNT WHICH SEEMED HIGH, SO HE LOWERED THE AMOUNT, BUT HE SAID THAT HIS BLOOD GLUCOSE READING STILL DROPPED TO 40 MG/DL. HE SAID THAT HE ADJUSTED HIS INSULIN SENSITIVITY SETTINGS AND NOTICED A SLIGHT IMPROVEMENT. THE MOST RECENT BLOOD GLUCOSE READING WAS 107 MG/DL. NO ADMISSION FOR MEDICAL TREATMENT WAS REPORTED. THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN AS WAS SHOWN ON THE STATUS SCREEN. HE REPORTED MORE PHYSICAL ACTIVITY RECENTLY AND THAT HE HAD BEEN TAKING A MEDICATION FOR HIS KIDNEYS THAT LOWERED HIS BLOOD PRESSURE. THE DEVICE WENT THROUGH AN AIRPORT BODY SCANNER BUT PASSED THE DISPLACEMENT TEST. ADVISED HIM TO CONSULT A DOCTOR REGARDING LOW BLOOD GLUCOSE. NOTHING FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724123 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention