BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150097 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34842
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS HAVING ALLERGIC SKIN REACTION FROM THE SENSOR OVERTAPE AND HAD LOW BLOOD GLUCOSE OF 46 MG/DL 3 DAYS AGO. OFFERED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 47 MG/DL. CUSTOMER STATED THAT SHE TREATED LOW BLOOD GLUCOSE WITH FOOD. CUSTOMER ALSO STATED THAT SHE SUFFERED HIGH BLOOD GLUCOSE TOO BUT BELIEVES IT WAS BECAUSE OF HER SCHEDULE. CUSTOMER DECLINED TO TROUBLESHOOT STATED SHE KNEW WHY SHE HAD LOW BLOOD GLUCOSE BECAUSE OF HER HECTIC SCHEDULE NAD ALSO INDICATED THAT HIGH BLOOD GLUCOSE WAS DUE TO OVERDOSE IT WITH FOOD. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHED ON THE SCREEN. CUSTOMER RAN A SELFTEST AND THE INSULIN PUMP PASSED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626990 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR