BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123617 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29683
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARMS NOTED. DEVICE HAD MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME AT 4.0 LBS DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. MOTOR PASSED MOTOR TEST. DEVICE HAD MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING INSULIN BOLUS DELIVERY. CUSTOMER REPORTED THAT SHE HAS HAD ISSUES AND HAD TO BE HOSPITALIZED. BLOOD GLUCOSE IS 520 MG/DL; TRYING TO GIVE AN INSULIN BOLUS CORRECTION. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS ABLE TO COMPLETE THE REWIND SEQUENCE. BLOOD GLUCOSE AT THE TIME OF THE HOSPITAL ADMISSION WAS OVER 600 MG/DL. CUSTOMER EXPERIENCED IRRITABILITY, THROAT IS DRY AND HEADACHE. CUSTOMER STATED THAT THE CANNULA DID NOT GO INTO HER BODY AND SHE THOUGHT SHE WAS GETTING INSULIN BUT IT WAS LEAKING OUT OF THE CANNULA. TREATED WITH INSULIN DRIP AND MANUAL INJECTION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600107 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP A000290377

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization