BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 5211974 · Received November 9, 2015

    Report

    Report Number
    2032227-2015-64352
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A BOLUS ANOMALY ON THE INSULIN PUMP. CUSTOMER REPORTED THE INSULIN PUMP DELIVERED THE SAME BOLUS TWICE WITHIN 6 MINUTES OF EACH OTHER. THE CUSTOMER REPORTED THEIR BLOOD GLUCOSE WAS 5.3 MMOL/L AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED 16 UNITS OF ACTIVE INSULIN WAS DELIVERED TO THEIR BODY AS A RESULT. THE CUSTOMER WAS ABLE TO CORRECT THEIR BLOOD GLUCOSE WITH FOOD. TROUBLESHOOTING WAS NOT COMPLETED FOR THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742441 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711B

    Patients

    Seq Age Sex Outcome Treatment
    1