BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1201854 · Received October 15, 2008

    Report

    Report Number
    3004209178-2008-00850
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE 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 HE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 29 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER STATED THAT HE HAD LAST CHANGED HIS INFUSION SET THE DAY PRIOR TO THE EVENT, BUT HE WAS NOT CONNECTED TO THE INSULIN PUMP DURING PRIMING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization