BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1812233 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82576
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 HAD A FLU AND WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT THE DEVICE HAD FREQUENT NO DELIVERY ALARMS. THE BLOOD GLUCOSE READING WAS 473MG/DL. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER HAS BEEN WORKING WITH HER ENDOCRINOLOGIST TO ADJUST THE BASALS AND PROGRAMMING. IT WAS ALSO STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE FOR SEVERAL MONTHS. THE CUSTOMER MENTIONED THAT EVERY TIME SHE HAD THE FLU, SHE ENDED IN THE HOSPITAL TO RECEIVE FLUIDS AND TREATMENT, AS SHE USUALLY VOMITS, WHICH CAUSES HER TO HAVE A DIABETES KETOACIDOSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization