BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2142381 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01527
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    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 WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING THAT WAS OUT OF RANGE. THE WIFE FELT THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. THE WIFE STATED THAT THE CUSTOMER DID NOT CHANGE THE INFUSION SET THAT DAY, AS IT WAS ONLY ONE DAY OLD. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP DID NOT HAVE THE CORRECT TIME AND DATE. ASSISTED WITH THE CORRECT PROGRAMMING. ALSO, FOUND MULTIPLE NO DELIVERY AND OTHER ERROR ALARMS IN THE ALARM HISTORY. EXPLAINED THE NO DELIVERY ALARMS TO THE CUSTOMER'S WIFE. SHE STATED THAT SHE WOULD MONITOR THE CUSTOMER'S BLOOD GLUCOSE LEVELS, AND CALL BACK IF FURTHER ASSISTANCE WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508RUT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization