BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LCAS PRDGM INS SK EN LN

    MDR report key: 1040212 · Received May 8, 2008

    Report

    Report Number
    2032227-2008-00793
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CUSTOMER INITIALLY CALLED TO REPORT A NO DELIVERY ALARM DURING A BOLUS. THE CUSTOMER HAD ALREADY CHANGED THE INFUSION SET. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME TEST WITHOUT GIVING ANOTHER ALARM. THE CUSTOMER THEN STATED THAT SHE WAS IN THE HOSPITAL BECAUSE OF HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WAS WORKING PROPERLY. EXPLAINED THE NO DELIVERY ALARM AND ITS POSSIBLE CAUSES. ADVISED THE CUSTOMER TO SPEAK WITH HER DOCTOR ABOUT USING OTHER INSERTION SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LCAS PRDGM INS SK EN LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization