BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAB PRDGM INSULIN BLUE

    MDR report key: 1791789 · Received August 4, 2010

    Report

    Report Number
    3004209178-2010-82351
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DELIVERED AN UNEXPECTED BOLUS OF 19 UNITS AND THE PARAMEDICS WERE CALLED AND TREATED HIS LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAB PRDGM INSULIN BLUE INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization