BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6037520 · Received October 18, 2016

    Report

    Report Number
    2032227-2016-32811
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HAD BEEN HAVING LOW BLOOD GLUCOSE EVENTS. THE PATIENT RECENTLY HAD A LOW BLOOD GLUCOSE OF 47 MG/DL AND SHE TREATED WITH HONEY. THE CUSTOMER AND HER DOCTOR COULD NOT EXPLAIN THE HYPOGLYCEMIC EVENT; THE PATIENT FELT LIKE GOD WAS HEALING HER DIABETES. TROUBLESHOOTING WAS DECLINED FOR THE INSULIN PUMP DUE TO GOD'S HEALING. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687969 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other