BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1000488 · Received February 21, 2008

    Report

    Report Number
    3004209178-2008-00136
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 HYPOGLYCEMIA. THE CUSTOMER STATED THAT HE WENT TO BED AND DID NOT WAKE UP THE NEXT DAY, SO HE WAS TAKEN TO THE HOSPITAL WHERE HIS BLOOD GLUCOSE READING WAS 190 MG/DL. THE CUSTOMER STATED THAT THE HOSPITAL STAFF PERFORMED TESTING ON HIM AND THAT HE WAS FINE. THE CUSTOMER REPORTED THAT HIS DOCTOR STATED THAT THE CAUSE OF THE EVENT WAS HYPOGLYCEMIA. THE CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP BECAUSE HE FEELS THAT THE CAUSE OF THE EVENT WAS AN ERROR ON HIS PART. 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 YR Hospitalization