BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4151608 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34645
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THAT THE CUSTOMER WORE THE PUMP IN HER BRA IN THE SUMMER. CUSTOMER STATED THAT SHE ALWAYS PLACED HER PUMP IN A POCKET IN HER SPORTS BRA AND WOULD ALCOHOL WIPE IT DOWN AFTER. CUSTOMER ALSO STATED THAT SHE DID THIS FOR HER DAILY RUN AND WOUND UP RUINING HER PUMP FROM SWEATING AND THE HUMIDITY. CUSTOMER REPORTED THAT THE BUTTON ERROR ALARM WOULD NOT CLEAR. CUSTOMER WAS WITHOUT A PUMP FOR 3 DAYS BEFORE MEDTRONIC COULD GET A NEW ONE SENT TO HER. CUSTOMER DID NOT HAVE A PLEASANT EXPERIENCE BEING ON LONG ACTING INSULIN FOR THE FIRST TIME IN 13 YEARS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633335 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1