BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1092043 · Received July 31, 2008

    Report

    Report Number
    3004209178-2008-00571
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 534 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT THE CUSTOMER HAD BEEN RECEIVING NO DELIVERY ALARMS PRIOR TO THE EVENT AND HAD NOT ATTEMPTED A SET CHANGE. IT WAS ADVISED THAT THE CUSTOMER CALL TO PERFORM TROUBLESHOOTING ANY TIME SHE RECEIVES AN ALARM ON THE INSULIN PUMP. THE INSULIN PUMP PASSED THE PRIME TEST. IT WAS REPORTED THAT AFTER THE EVENT THE CUSTOMER WAS PLACED ON AN INSULIN DRIP, AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. HOWEVER, WHENEVER THE CUSTOMER WAS PUT BACK ON THE INSULIN PUMP, HER BLOOD GLUCOSE LEVELS ELEVATED AGAIN. 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