BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090380 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23080
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. 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 CALLED TO REPORT HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 509 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING WAS 105 MG/DL LAST NIGHT WHEN SHE ATE SOME CEREAL WITH MILK AND BOLUSED. BLOOD GLUCOSE READING WENT UP TO 300 MG/DL IN THE MIDDLE OF THE NIGHT AND THERE WERE NO ALERTS. CUSTOMER DISCONNECTED FROM THE INSULIN PUMP WHEN HER BLOOD GLUCOSE WENT UP TO 509 MG/DL. TROUBLESHOOTING WAS PERFORMED. SMALL AIR BUBBLES WERE FOUND IN THE TUBING OF THE INFUSION SET. THE CANNULA WAS BENT ON THE INFUSION SET. FOUND A NO DELIVERY ALARM THAT THE CUSTOMER DID NOT HEAR. LOW RESERVOIR ALERTS WERE ALSO NOTED IN THE HISTORY FILE. ADVISED TO CHANGE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568726 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR