BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4862713 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-67875
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND INFECTION. CUSTOMER'S BLOOD GLUCOSE WAS 586 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL. CUSTOMER CAUSE OF HOSPITALIZATION AS PER HEALTHCARE PROVIDER WAS LUNG INFECTION, HIGH BLOOD GLUCOSE AND CELLULITIS. THE PATIENT IS STILL IN THE HOSPITAL. THE CUSTOMER DECLINED TROUBLESHOOTING AND SHE WOULD LIKE THE DEVICE BE REPLACED. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404915 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization