BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2621561 · Received June 19, 2012

    Report

    Report Number
    2032227-2012-06114
    Event Type
    Malfunction
    Date Received
    June 19, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    THE CUSTOMER'S DOCTOR CALLED TO REPORT THAT THE CUSTOMER HAS BEEN EXPERIENCING ERRATIC BLOOD GLUCOSE LEVELS. THE DOCTOR FELT THAT THE INSULIN PUMP WAS DELIVERING UNNECESSARY AMOUNTS OF INSULIN, CAUSING THE CUSTOMER TO EXPERIENCE LOW BLOOD GLUCOSE LEVELS. THE DOCTOR DID NOT HAVE THE INSULIN PUMP WITH HER AT THE TIME OF THE CALL. ADVISED THE DOCTOR TO HAVE THE CUSTOMER CALL IN FOR TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR