BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY CAP

    MDR report key: 4090514 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23165
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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 CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR AND HAD A BLANK DISPLAY. THE BLOOD GLUCOSE READING WAS 492 MG/DL, WHICH THE CUSTOMER TREATED WITH A MANUAL INJECTION OF 13 UNITS. SHE DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. SHE ALSO OBSERVED A CRACK ON THE BATTERY COMPARTMENT THREADING. EXPLAINED TO THE CUSTOMER THAT THE INSULIN PUMP HAD EXPERIENCED AN UNEXPECTED RESTART. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP AND THAT A REPLACEMENT BATTERY CAP WOULD BE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570307 BATTERY CAP CGM MDS MEDTRONIC MINIMED MMT-638L

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR