BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUISON PUMP

    MDR report key: 501092 · Received December 16, 2003

    Report

    Report Number
    2032227-2003-01407
    Event Type
    Injury
    Date Received
    December 16, 2003
    Date of Event
    November 20, 2003
    Report Date
    November 20, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DKA. THE BACK PRESSURE SENSITIVE ALARM HAD OCCURRED MANY TIMES. IT INDICATED THAT THE CUSTOMER DID NOT DO AN ENTIRE SET CHANGE OR FOLLOW THE TWO HBG RULE. THE PROGRAMMING WAS ACCURATE AND THE PUMP PASSED THE FUNCTIONAL TESTS. THE CUSTOMER WAS EDUCATED ON THE ALARM AND WAS INSTRUCTED TO FOLLOW THE TWO HBG RULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUISON PUMP INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization