BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722PNAS PRDGM INS SK EN PW

    MDR report key: 1161663 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01589
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER WAS TAKE BY PARAMEDICS TO THE HOSPITAL DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 20 MG/DL. THE CUSTOMER'S WIFE STATED THAT PRIOR TO THE EVENT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS, SO HE CHANGED HIS INFUSION SET AND TOOK A MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED SEVERAL ALARMS ON THE INSULIN PUMP. IT WAS ADVISED THAT THE CUSTOMER REVERT TO BACKUP PLAN TO TREAT HIS DIABETES PER HIS DOCTOR'S INSTRUCTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization