BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 4973145 · Received August 5, 2015

    Report

    Report Number
    2032227-2015-25355
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G 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.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR POWER ERROR ALARMS. THE DETAILED TRACE ANALYSIS CONFIRMED THAT THE ALARM WAS TRIGGERED WHEN THE BACKUP BATTERY UNLOADED VOLTAGE WAS LESS THAN 3.7V FOR 240 CONSECUTIVE MINUTES. ANALYSIS OF THE MICRO TIMER IN THE DETAILED TRACE CONFIRMED THAT THE ROOT CAUSE WAS THE NON-SLEEP ANOMALY SOFTWARE ERROR. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND KEYPAD OVERLAY TEXTURE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A POWER SYSTEM ERROR ALARM ON THE DEVICE. CUSTOMER'S BLOOD GLUCOSE WAS 3 MMOL/L. CUSTOMER REVIEWED THE ALARM HISTORY AND NOTED THAT THE ALARMS WERE GOING IN 4 HOUR WINDOWS. CUSTOMER HAS REWOUND AND REPLACED THE SET ON EVERY OCCURRENCE. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518983 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711P

    Patients

    Seq Age Sex Outcome Treatment
    1