BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1092463 · Received August 1, 2008

    Report

    Report Number
    2032227-2008-01328
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 STATED THAT HE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 500 MG/DL. THE CUSTOMER STATED THAT HE HAD NOT SET THE BASAL RATES ON THIS INSULIN PUMP AFTER RECEIVING IT AS A REPLACEMENT. THE CUSTOMER ALSO STATED THAT HE HAD BEEN TREATING THE HIGH BLOOD GLUCOSE READINGS WITH MANUAL INJECTIONS. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN UNTIL HE COULD DISCUSS HIS BASAL SETTINGS WITH HIS DOCTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization