BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAL PRDGM INSULIN CLEAR

    MDR report key: 1902389 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83317
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 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
    IL, US
    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

    THE CUSTOMER REPORTED THAT PARAMEDICS WERE CALLED AND SHE WAS TAKEN TO THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET AND INSERTED A NEW RESERVOIR WITHOUT REWINDING THE INFUSION PUMP. THE CUSTOMER STATED THAT SHE ATTEMPTED WITH THREE FILLED RESERVOIRS AND SHE DOES NOT KNOW HOW MUCH INSULIN WENT IN HER BODY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization