BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4015030 · Received August 18, 2014

    Report

    Report Number
    3004209178-2014-94579
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD FAILURE WHEN HE CHANGED HIS INFUSION SET SOMETHING OCCURRED WHERE THE INSULIN PUMP EMPTIED THE ENTIRE RESERVOIR. CUSTOMER STATED HE HAD LOW BLOOD GLUCOSE ALL DAY. AFTER EATING ALL DAY, THE INSULIN PUMP DID NOT ALARM AND READING WAS 100-126 BUT HIS BLOOD GLUCOSE WAS OVER 400 MG/DL. CUSTOMER STATED AT NIGHT READINGS WILL BE LOW 50'S BUT HIS BLOOD GLUCOSE READING WAS 126 MG/DL. CUSTOMER BLOOD GLUCOSE WENT DOWN TO 36 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER DOES NOT WANT INSULIN PUMP REPLACEMENT. CUSTOMER WAS ADVISED TO CALIBRATE 3-4 TIMES A DAY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495313 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L