BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3935278 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03803
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    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

    THE CUSTOMER CALLED IN TO REPORT THAT HIS INSULIN PUMP WAS RECEIVING MULTIPLE MOTOR ERROR ALARMS DURING A BOLUS AND BASAL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 389 MG/DL. THE CUSTOMER STATES THAT THE ALARM OCCURRED SEVERAL TIMES THROUGHOUT THE NIGHT AND THAT THIS WAS THE FIRST INDICATION THAT SOMETHING WAS WRONG WITH THE INSULIN PUMP. THE CUSTOMER SAID THAT THE SIGNIFICANT EVENTS LEADING TO THE EVENT WAS THAT THE BELT CLIP WAS LOOSE BUT HE DAD NOT HIT THE INSULIN PUMP UP AGAINST ANYTHING NOR HAD HE DROPPED IT. WE ASSISTED THE CUSTOMER WITH CLEARING THE ALARM. WE ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413598 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR