BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183060 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40013
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE AND HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT HE HAD INCREDIBLE HIGH BLOOD GLUCOSE AND INCREDIBLE LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. ADVISED CUSTOMER THE 2 HIGH BLOOD GLUCOSE. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. LAST BLOOD GLUCOSE WAS 534 MG/DL AND CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT HE HAD LOW BLOOD GLUCOSE AND PASSED OUT. PARAMEDICS CAME AND HE SPENT A NIGHT IN THE HOSPITAL. TROUBLESHOOTING WAS DONE FOR LOW BLOOD GLUCOSE. ASSISTED THE CUSTOMER TO PERFORM DISPLACEMENT TEST AND TEST PASSED. ADVISED THE CUSTOMER TO CONTACT HEALTH CARE PROVIDER REGARDING HIGHS AND LOWS BLOOD GLUCOSE. THE INSULIN PUMP APPEARS TO BE FUNCTIONING. THE CUSTOMER'S BLOOD GLUCOSE CAME DOWN TO 411 MG/DL DURING THE CALL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660902 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization