BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1142791 · Received August 27, 2008

    Report

    Report Number
    3004209178-2008-00676
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 280. IT WAS REPORTED THAT THE CUSTOMER WAS VERY ILL AND VOMITING FREQUENTLY, SO SHE WAS TAKEN OFF OF THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. IT WAS FOUND THAT THE CUSTOMER HAD CHANGED HER INFUSION SET PRIOR TO BEING HOSPITALIZED, BUT SHE HAD NOT CHANGED THE RESERVOIR. THE CUSTOMER WAS ADVISED TO CHANGE THE RESERVOIR AT THE SAME TIME AS THE INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization