BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 640G BLACK 3ML MM

    MDR report key: 5364235 · Received January 13, 2016

    Report

    Report Number
    3004209178-2016-81563
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    December 29, 2015
    Report Date
    October 27, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED SELF-TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. HOWEVER, FORMATTED HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 53 WITH LINE 0 AND FILE 0. WE WERE UNABLE TO DETERMINED ROOT CAUSE. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND CASE. IT WAS MONITORED FOR 24 HOURS AND NO BLANK DISPLAY ANOMALIES NOTED.

    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. 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. 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 15 MMOL/L AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ALSO ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22757 KIT 640G BLACK 3ML MM INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1751WWK

    Patients

    Seq Age Sex Outcome Treatment
    1