BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142116 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33400
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    CUSTOMER REPORTED SHE WAS HAVING ISSUES WITH THE INSULIN PUMP AND SENSOR. CUSTOMER STATED THE READINGS ARE INACCURATE. THE DEVICE WENT INTO THRESHOLD SUSPEND. BLOOD GLUCOSE WAS 336 MG/DL AND THE SENSOR WAS READING 66 MG/DL. CUSTOMER WAS REALLY CONCERNED BECAUSE ALSO STATED SHE WAS HOSPITALIZED FOR FOUR DAYS. CUSTOMER STATED HER BLOOD GLUCOSE WAS 500 MG/DL WHEN SHE WAS HOSPITALIZED TREATED WITH THE DEVICE THEN MANUAL INJECTIONS. SYMPTOM WAS VOMITING AND HIGHS. CUSTOMER WAS DEHYDRATED AND HAD DIABETIC KETOACIDOSIS. THE INFUSION SITE WAS REMOVED AT THE HOSPITAL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621235 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR