BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1890141 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83241
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. ALL THE BOLUSES DELIVERED COMPLETELY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE BOLUS HISTORY. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED IN THE INTENSIVE CARE UNIT FOR HIGH BLOOD GLUCOSE OF 360 MG/DL. THE CUSTOMER STATED THAT SHE BELIEVES THE DEVICE WAS NOT ADMINISTERING THE DOSES THAT SHE NEEDS, AND IT WAS NOT DELIVERING THE BOLUSES FAST ENOUGH OR AT ALL. THE CUSTOMER STATED THAT SHE TRIED TO STABILIZE HER BLOOD GLUCOSE WITH THE INSULIN PUMP THERAPY, BUT HER GLUCOSE LEVEL WAS RUNNING HIGH AGAIN. THE INFUSION SET, RESERVOIR, AND THE INSULIN WERE CHANGED TO STABILIZE HER BLOOD GLUCOSE. THE CUSTOMER STATED THAT DURING REWIND, SHE DID NOT HEAR THE MOTOR, AND IT TOOK LONGER TO REWIND AND PRIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization