BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3923700 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-86583
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    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

    CUSTOMER REPORTED A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER IS A NURSE. ON (B)(6) 2014, SHE ATE LUNCH AND GAVE HERSELF A BOLUS. AFTER LUNCH, HER BLOOD GLUCOSE WAS OVER 500 MG/DL, SO SHE GAVE HERSELF A CORRECTION BOLUS. WHEN SHE ARRIVED HOME THAT NIGHT, HER BLOOD GLUCOSE WAS OVER 600 MG/DL. SHE TOOK SEVERAL CORRECTION BOLUSES THROUGHOUT THE NIGHT. WHEN SHE WOKE UP SHE WAS FALLING DOWN, SO SHE WENT TO THE EMERGENCY ROOM. HER BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS ABOUT 750 MG/DL. SHE WAS TREATED WITH AN INSULIN DRIP AND IV FLUIDS. SHE WAS TAKEN OFF THE INSULIN PUMP AT ADMISSION AND CONTINUED USE WHEN SHE WAS RELEASED AFTER A FEW DAYS. SHE WAS LATER READMITTED DUE TO SHORTNESS OF BREATH AND DIFFICULTY BREATHING. DURING THE SECOND HOSPITALIZATION, SHE REMAINED ON THE DEVICE AND HER BLOOD GLUCOSE LEVELS WERE STABLE. CUSTOMER BELIEVES HER HIGH BLOOD GLUCOSE LEVEL WAS A RESULT OF A VIRUS SHE PICKED UP WHILE WORKING IN THE HOSPITAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399631 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization