BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1023245 · Received March 31, 2008

    Report

    Report Number
    3004209178-2008-00221
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 SHE WAS CONNECTED DURING PRIMING AND ACCIDENTLY DELIVERED UNNEEDED INSULIN. THE CUSTOMER STATED SHE WAS TREATED BY PARAMEDICS FOR HYPOGLYCEMIA, BUT WAS NOT TAKEN TO THE HOSPITAL. THE CUSTOMER STATED SHE WAS TRAINED ON THE INSULIN PUMP, HOWEVER SHE DID NOT UNDERSTAND THE VERBIAGE OF THE INSULIN PUMP FUNCTIONS. IT WAS ARRANGED TO HAVE THE CUSTOMER WORK WITH HER TRAINER TO PROVIDE FURTHER INSTRUCTION ON HOW TO USE THE INSULIN PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention