BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5211969 · Received November 9, 2015

    Report

    Report Number
    2032227-2015-64297
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 25, 2015
    Report Date
    October 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED SELF-TEST, UNEXPECTED ERROR TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP ALARMED BUTTON ERROR FOLLOWED BY INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON LCD WINDOW.

    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. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 8.2 MMOL/L. THE CUSTOMER STATED THAT THERE IS NO SIGNIFICANT EVENT LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN UNTIL REPLACEMENT PUMP ARRIVES. THE CUSTOMER METER WAS STOLEN AND ADVISED TO CONTACT LOCAL OFFICE FOR REPLACEMENT METER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742411 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMB

    Patients

    Seq Age Sex Outcome Treatment
    1