BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-554WWP PRDGM INS PL EN

    MDR report key: 1874008 · Received October 15, 2010

    Report

    Report Number
    3004209178-2010-83135
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT A BOLUS WAS DELIVERED AND IT WAS NOT APPEARING IN THE BOLUS HISTORY. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE HAS BEEN HIGH FOR THE PAST TEN DAYS. IT WAS STATED THAT THE NUMBERS APPEARED ON THE SCREEN, BUT IT TOOK A WHILE TO COMPLETE. THE MOTHER STATED THAT THE BOLUS HISTORY WAS REVIEWED WHEN THE CUSTOMER CAME BACK FROM SCHOOL AND FOUND NO BOLUS WAS GIVEN. THE MOTHER CALLED TO THE SCHOOL, WHO ASSURED HER THAT THEY SAW THE BOLUS DELIVERED. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 19 MMOL/L IN THE MORNING, AND AN HOUR LATER HER GLUCOSE LEVEL WAS DOWN TO 2.2 MMOL/L. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-554WWP PRDGM INS PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1