BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1031545 · Received April 18, 2008

    Report

    Report Number
    3004209178-2008-00256
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED FOR THE EVENT. THE CUSTOMER ALSO STATED THAT HE WAS SUFFERING FROM THE FLU AND HIS BLOOD GLUCOSE LEVELS WERE UNUSUALLY HIGH. CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVELS WERE FINE DURING THE HOSPITALIZATION WHILE HE WAS ON AN INSULIN DRIP. HOWEVER, ONCE HE WOULD GET BACK ON THE INSULIN PUMP, THE BLOOD GLUCOSE LEVELS WOULD BEGIN TO RISE AGAIN. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization