BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4200473 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42309
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS MONITORED. ALL OPERATING CURRENTS TESTED WITHIN SPECIFICATION RANGE. NO FAILED BATTERY TEST ALARMS, WEAK BATTERY ALARMS, OR UNEXPECTED OFF NO POWER ALARMS NOTED. PUMP PASSED PRIME/A33, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOTOR ERROR ALARMS NOTED. DRIED INSULIN ON MOTOR SLIDE AND LIGHT CORROSION NOTED ON MOTOR HOME SWITCH. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOMER HAVE RECEIVED SEVERAL ALARMS. CUSTOMER RECEIVED A WEAK / BAD BATTERY ALARM, FAILED BATTERY TEST ALARM AND MOTOR ERROR ALARM. CUSTOMER STATES INSULIN PUMP RECEIVED A NO POWER ALERT WITHOUT RECEIVING A LOW BATTERY ALERT. CUSTOMER'S BLOOD GLUCOSE WAS 3.5 MMOL/L, WHICH WAS TREATED WITH FOOD. AFTER TROUBLESHOOTING, 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
    678977 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CAL

    Patients

    Seq Age Sex Outcome Treatment
    1