BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4233544 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48869
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED A NO DELIVERY ALARM DURING A MANUAL PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 364 MG/DL. THE CUSTOMER STATED THEY HAD TREATED THEIR BLOOD GLUCOSE WITH THE INSULIN PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED AS THE CUSTOMER DID NOT HAVE A PUSH PLUNGER. CUSTOMER WAS ADVISED TO CHANGE THEIR INFUSION SET AND RESERVOIR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715242 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR