BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103563 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26427
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 PASSED OUT, EXPERIENCED LOW BLOOD GLUCOSE LEVELS, AND REQUIRED MEDICAL INTERVENTION FROM PARAMEDICS TO HANDLE THE SITUATION. THE BLOOD GLUCOSE READING WAS 27 MG/DL. SHE STATED THAT SHE DID NOT REMEMBER WHETHER HER INSULIN PUMP HAD ALERTED A LOW PREDICTIVE WARNING. SHE NOTED THAT WHEN SHE HAD CHECKED HER BLOOD GLUCOSE THE FIRST TIME, IT WAS 51 MG/DL, AND BY THE TIME THE PARAMEDICS ARRIVED, IT WAS 27 MG/DL. SHE STATED THAT THE CERTIFIED PUMP TRAINER ARRIVED AND FOUND THAT SHE HAD SOMEHOW CHANGED HER BASAL SETTINGS; SHE WAS REPORTED TO HAVE BEEN RECEIVING TOO MUCH INSULIN. SHE STATED THAT SHE THOUGHT SHE HAD CHANGED THE SETTINGS AT NIGHT WHEN THE DEVICE WAS GOING OFF AND SHE DID NOT KNOW HOW TO STOP IT FROM ALARMING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583916 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention