BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4900518 · Received July 8, 2015

    Report

    Report Number
    2032227-2015-21426
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 REPORTED THAT HE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 511 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS PRIOR TO HIS ADMISSION. THE CUSTOMER STATED THAT HE WOULD PROGRAM A BOLUS OF 9 UNITS AND ONLY RECEIVE 1.9 UNITS. THE CUSTOMER COULD NOT TROUBLESHOOT AS HE DID NOT HAVE THE INSULIN PUMP WITH HIM AT THE HOSPITAL. THE CUSTOMER WILL CALL BACK TO COMPLETE TROUBLESHOOTING AND WILL NOT RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443540 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization