BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1760437 · Received July 13, 2010

    Report

    Report Number
    3004209178-2010-81975
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    November 23, 2009
    Report Date
    June 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH POTASSIUM AND DIABETES KETOACIDOSIS LAST YEAR. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVEL WAS TOO HIGH TO READ ON THE METER. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE DOES NOT BELIEVE IT HAD ANYTHING TO DO WITH THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization