BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1853371 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82978
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 800MG/DL. THE CUSTOMER STATED THAT THE BATTERY WAS REMOVED OUT OF HER INSULIN PUMP AT HOSPITAL, AND THE TIME AND DATE WAS RESET. THE CUSTOMER ALSO STATED THAT THE DEVICE ALARMED AN ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY SEVERAL TIMES BEFORE SHE WENT INTO HYPERGLYCEMIA, BUT SHE DID NOT KNOW WHAT THE ALARM MEANT. RAN A FIXED PRIME AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization