BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1781294 · Received July 28, 2010

    Report

    Report Number
    3004209178-2010-82187
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED. DURING THE CALL, THE CUSTOMER MENTIONED THAT SHE WAS HOSPITALIZED FOR HYPOGLYCEMIA AND DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT SHE WAS ADMITTED WITH A GLUCOSE LEVEL OF 27MG/DL AND THEN THE GLUCOSE LEVEL INCREASED TO 500MG/DL. THE CUSTOMER FELL DIZZINESS, THIRST, AND CONSTANT URINATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization