BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1811997 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-82520
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SEVERAL TIMES IN THE PAST THREE MONTHS FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE MOTHER STATED THAT THE LAST TIME THE CAUSE OF THE CUSTOMER HOSPITALIZATION WAS DIABETES KETOACIDOSIS AND SITE INFECTIONS. THE MOTHER STATED THAT FOR THE PAST SEVERAL MONTHS, THE CUSTOMER'S BLOOD GLUCOSE HAD NOT DECREASED BELOW 500 MG/DL. THE MOTHER ALSO STATED THAT THEY CHANGED THE SITES AND THE INFUSION SETS NUMEROUS TIMES, BUT IT DID NOT RESOLVE THE PROBLEM. THE INSULIN PUMP WAS DISCONNECTED, AND THE CUSTOMER'S GLUCOSE LEVEL CAME BACK TO NORMAL ONCE IT WAS TREATED WITH MANUAL INJECTIONS. 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 MM5-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization