BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 6174325 · Received December 14, 2016

    Report

    Report Number
    2032227-2016-49909
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    September 20, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED DISPLACEMENT TEST AND REWIND TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. NO UNEXPECTED LOW BATTERY ALARM NOTED ON LONG HISTORY DOWNLOAD FILE. POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WERE WITHIN SPEC RANGE. THE PUMP WAS RECEIVED WITH CRACKED KEYPAD OVERLAY AT SELECT BUTTON, MISSING RETAINER, SCRATCHED CASE, MISSING RESERVOIR TUBE O-RING AND KEYPAD OVERLAY TEXTURE DAMAGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THEIR INSULIN PUMP. IT WAS REPORTED THAT THE PUMP HAD SHORT BATTERY LIFE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825163 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1710K

    Patients

    Seq Age Sex Outcome Treatment
    1