BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4133766 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32023
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO BAD BATTERY ALARM AND NO FAILED BATTERY ALARM NOTED. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED CRACKED CASE DISPLAY WINDOW CORNER. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOMER RECEIVED A FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 403 MG/DL, WHICH WAS TREATED WITH INSULIN PUMP. AFTER TROUBLESHOOTING, CUSTOMER STILL RECEIVED A FAILED BATTERY TEST. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611646 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention