BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4103253 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26497
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 HAD A HIGH BLOOD GLUCOSE READING OF 450 MG/DL. THE CUSTOMER STATED THAT HE HAD PERFORMED A BOLUS BEFORE EATING, AND NOW AFTER HAVING EATEN, THE BLOOD GLUCOSE WAS HIGHER THAN BEFORE. HE DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE BECAUSE HE WAS AT WORK. ADVISED THE CUSTOMER THAT IF THE BLOOD GLUCOSE CONTINUED TO RISE, TO REVERT TO TREATMENT BY MANUAL INJECTION. ADVISED THE CUSTOMER TO CALL BACK FOR TROUBLESHOOTING. THE CUSTOMER CALLED BACK LATER REGARDING A LOW BATTERY ALARM, WHICH WAS RESOLVED UPON REPLACEMENT OF THE BATTERY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581716 INSULIN INFUSION PUMP CGM MDS MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR