BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141680 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33277
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 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
    CA
    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. (B)(4). REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-33271.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE CUSTOMER TOOK A BOLUS THIS MORNING, HIS BLOOD GLUCOSE LEVEL DROPPED TO 56 MG/DL. CUSTOMER STATED THAT HE DRANK ORANGE JUICE TO GET BLOOD GLUCOSE LEVEL BACK TO 138 MG/DL. CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVEL DROPPED FROM 556 MG/DL TO 56 MG/DL. CUSTOMER HAS TREATED WITH FOOD AND HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR 24 HOURS. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF ISSUES PERSIST. CUSTOMER WAS ALSO ADVISED TO CONTACT HEALTH CARE PROFESSIONAL FOR OTHER POSSIBLE CAUSES FOR QUICK BLOOD GLUCOSE DROP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621143 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR