BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1871242 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-83065
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING TWO LOW EPISODES OF LOW BLOOD GLUCOSE, AND THE PARAMEDICS WERE CALLED AND TREATED HIM. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 94MG/DL. THE CUSTOMER STATED THAT HE IS A BRITTLE DIABETIC, AND HIS GLUCOSE LEVEL CAN GO FROM 31MG/DL TO 500MG/DL IN A MATTER OF MINS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. VERIFIED THAT THE AMOUNT OF INSULIN IN THE RESERVOIR MATCHED TO THE STATUS SCREEN ON THE DEVICE. NO FURTHER INFO 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention