BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAS PRDGM INSULIN PUMP

    MDR report key: 7907458 · Received September 25, 2018

    Report

    Report Number
    2032227-2018-33170
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE INSULIN PUMP RAN OUT OF BATTERIES AND THEN IT DIDN'T WORK AFTER CHANGING THE BATTERY. THE BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE CUSTOMER TRIED DIFFERENT BATTERIES BUT THE SCREEN WAS BLANK. THE INSULIN PUMP DID NOT DISPLAY ANYTHING. THE PRODUCT WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746432 NAS PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1