BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 5341033 · Received January 4, 2016

    Report

    Report Number
    2032227-2015-80591
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 18, 2015
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. DEVICE PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. DEVICE WAS TESTED WITH A WATER FILL RESERVOIR. UNITS LEFT ON STATUS SCREEN MATCHED PROPERLY WITH UNITS LEFT ON TEST RESERVOIR. NO ANOMALIES NOTED. DEVICE RECEIVED WITH STAINED SERIAL NUMBER LABEL AND MINOR SCRATCHES ON KCD WINDOW.

    Description of Event or Problem · 1

    THE NURSE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SHOWING ZERO UNITS OF INSULIN WHILE THE RESERVOIR HAD 129 UNITS OF INSULIN. THE CUSTOMER'S BLOOD GLUCOSE WAS 16 MMOL/L AT THE TIME OF INCIDENT. THE NURSE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 19.1 MMOL/L PRIOR TO THE INCIDENT. THE NURSE PERFORMED DISPLACEMENT TEST AND SELF-TEST. THE INSULIN PUMP PASSED BOTH DISPLACEMENT TEST AND SELF-TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K

    Patients

    Seq Age Sex Outcome Treatment
    1