BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234079 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82747
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DELIVERED A BOLUS THAT SHE DID NOT PROGRAM. REVIEWED THE BOLUS HISTORY AND FOUND A BOLUS WIZARD OF 9.95 UNITS. THE CUSTOMER'S BLOOD GLUCOSE WAS 74MG/DL. THE CUSTOMER STATED THAT SHE WAS SLEEPING AT THE TIME OF DELIVERING, AND DOES NOT FEEL THAT SHE COULD HAVE ACCIDENTALLY PRESSED ANY BUTTONS. THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE AND PARAMEDICS WERE CALLED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 32MG/DL BY THE TIME THE PARAMEDICS ARRIVED AT THERE HOME AND TREATED HER. REVIEWED PRIMING TECHNIQUE AND SEEM IT WAS CORRECT. CHECKED THE PROGRAMMING AND FOUND A DIFFERENCE OF 1.025 UNITS. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING HER INFUSION SET CHANGE. HAD CUSTOMER TO DISCONNECT FROM THE QUICK RELEASED AND TO REMOVE THE RESERVOIR FROM THE RESERVOIR COMPARTMENT. THE CUSTOMER STATED THAT THERE WERE 60 UNITS LEFT IN THE RESERVOIR. ADVISED THE CUSTOMER THAT THE INSULIN PUMP IS WORKING PROPERLY AND TO CONTINUE USING THE DEVICE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention