BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920842 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86569
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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 BY THE CUSTOMER THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVEL ON (B)(6) OF 2014. CUSTOMER STATED HER BLOOD GLUCOSE LEVEL WAS 36 MG/DL WHILE AT WORK WITH 3.4U OF INSULIN IN HER BODY AND IMMEDIATELY BEGAN TO DRINK A SODA AND ATE TWO FRUIT SNACK PACKS. CUSTOMER HAD SUPERVISOR DRIVE HER TO THE EMERGENCY ROOM AND WAS ADMITTED WITH A BLOOD GLUCOSE LEVEL OF 91 MG/DL. AFTER TREATMENT, CUSTOMER WAS ADVISED TO REST AND BLOOD GLUCOSE LEVEL WAS 350 MG/DL. CUSTOMER STATED SHE IS NEW TO THE INSULIN PUMP. ADVISED CUSTOMER TO CALL BACK WHEN SHE IS COMFORTABLE TO ENSURE THE DEVICE IS FUNCTIONING PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398267 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization