BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233693 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49203
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO 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 WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 500 MG/DL. THE CUSTOMER STATED THAT SHE EXPERIENCED NAUSEA, VOMITING AND DEHYDRATION. SHE WAS HOSPITALIZED FOR 3 DAYS, TREATED AND RELEASED. SHE STATED THAT SHE WAS HANDICAPPED AND HAD ISSUES WITH WHERE SHE COULD WEAR THE INSULIN PUMP AND GET TO IT. SHE NOTED THAT WHEN THE ISSUE OCCURRED, HER PANTS PULLED THE INFUSION SET OUT SO THAT SHE DID NOT RECEIVE INSULIN. SHE ADVISED THAT SHE DID NOT HAVE ENOUGH FAT FOR HER INSERTION SITE, SO SHE WAS TREATING WITH MANUAL INJECTIONS IN HER LEG. SHE ADVISED THAT SHE WAS TAKING A BREAK FROM THE INSULIN PUMP. SHE NOTED THAT SHE DID NOT HAVE ANY ISSUES SINCE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715179 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization