BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4203557 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-31670
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    NURSE

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED EXCESSIVE NO DELIVERY ALARMS ON CUSTOMER'S INSULIN PUMP. THIS IS A REPLACEMENT INSULIN PUMP SINCE THE LAST ONE WAS REPLACED DUE TO EXCESSIVE NO DELIVERY ALARMS. CUSTOMER RECEIVED THE NEW PUMP RECENTLY, BUT THE NO DELIVERY ALARMS PERSIST. THE DEVICE WOULD DELIVER ONE AND A HALF UNITS OF INSULIN BEFORE ALARMING NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE ROSE TO 400 MG/DL, SO CUSTOMER CONNECTED TO A DIFFERENT COMPANY'S INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LOWERED TO 158 MG/DL. WHILE CONNECTED TO THE MEDTRONIC DEVICE, CUSTOMER'S BLOOD GLUCOSE IS USUALLY BETWEEN 200 MG/DL AND 350 MG/DL. CUSTOMER HAS ALREADY DONE THE TROUBLESHOOTING HIMSELF. CUSTOMER WAS SENT DIFFERENT INFUSION SETS AND RESERVOIRS TO TRY OUT. CUSTOMER'S MOTHER CALLED BACK ABOUT A WEEK LATER AND STATED THE REPLACEMENT SUPPLIES SEEM TO BE WORKING WELL. CUSTOMER'S MOTHER IS A NURSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681680 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention