BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1210207 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-00869
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONA MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS TAKEN BY PARAMEDICS TO THE HOSPITAL DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT HIS WIFE WOKE UP DURING THE NIGHT AND FOUND HIM UNRESPONSIVE AND PERSPIRING HEAVILY. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER STATED THAT PRIOR TO THE EVENT HE RECEIVED AN ALARM ON THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HIS DIABETES. 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 OPERATIONA MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization