BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2212066 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01561
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 TERRITORY MANAGER CALLED TO REPORT THAT ONE OF HIS CUSTOMERS HAS AN INSULIN PUMP THAT HAS BEEN CHANGING THE FIXED PRIME DELIVERY FROM 0.3 TO 3.0 ON ITS OWN. THE CALLER ALSO STATED THAT THE DOCTOR HE WORKS WITH HAS HEARD OF THIS HAPPENING ON OTHER INSULIN PUMPS AS WELL. ADVISED THE CALLER TO HAVE THE CUSTOMER CALL IN FOR TROUBLESHOOTING AS THE CALLER WAS NOT WITH THE CUSTOMER, AND DID NOT HAVE THE INSULIN PUMP PRESENT. 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