BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4070438 · Received September 8, 2014

    Report

    Report Number
    2032227-2014-18971
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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 EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE SENSOR AND BLOOD GLUCOSE READINGS ALSO HAD DISCREPANCIES. THE FIRST SENSOR GLUCOSE READING WAS 160 MG/DL COMPARED TO THE BLOOD GLUCOSE READING OF 61 MG/DL. THE SECOND SENSOR GLUCOSE READING WAS 130 MG/DL COMPARED TO THE BLOOD GLUCOSE READING OF 47 MG/DL. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 192 MG/DL. THE CUSTOMER STATED THAT THE DEVICE NORMALLY HAS REGULATED WELL AND DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. HE DID NOT HAVE TIME TO TROUBLESHOOT OVER THE PHONE AND ADVISED THAT HE WOULD CALL BACK WHEN HAVING ISSUES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549239 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR