BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1812304 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82593
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DRAW AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 600MG/DL. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL WAS HIGH WHEN SHE WORK UP, AND WAIT FOR A FEW HOURS, BUT THE BLOOD GLUCOSE DID NOT DROP. THE CUSTOMER STATED THAT WHEN THE CANNULA WAS REMOVED IT APPEARED TO BE BENT. TROUBLESHOOTING WAS PERFORMED. THE BASALS AND BOLUSES ADDED UP PROPERLY IN THE DAILY TOTALS. THE CUSTOMER STATED THAT SHE ATTEMPTED TO DELIVER A BOLUS TWO DAYS BEFORE THE EVENT TO LOWER HER GLUCOSE, BUT THE BOLUS HISTORY DID NOT INDICATE ANY BOLUS WAS DELIVERED. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization