BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1853367 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82971
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-EL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 THAT A SERIES OF "9" WERE DISPLAYING. A BOLUS OF 0.5 UNITS WAS PROGRAMMED AND WAS DELIVERED SUCCESSFULLY. DURING THE CALL, THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 537MG/DL. TROUBLESHOOTING WAS PERFORMED. HAD CUSTOMER TO CHECK THE PRIME HISTORY AND FOUND THAT THE CUSTOMER DID NOT PRIME THE NEW INFUSION SET. THE CUSTOMER WAS INSTRUCTED TO REWIND, PRIME AND RECONNECT TO HER BODY. RAN A FIXED PRIME AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-EL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization