BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110573 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27419
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED A HOSPITALIZATION FOR HER HUSBAND'S HIGH BLOOD GLUCOSE. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 750 MG/DL. THE WIFE STATED HER HUSBAND HAD BEEN HOSPITALIZED WITH DIABETES KETOACIDOSIS. HE WAS BEING TREATED WITH AN INSULIN DRIP FOR HIS HIGH BLOOD GLUCOSE. THE WIFE STATED THE INSULIN PUMP APPEARED TO BE WORKING FINE AND DECLINED TO TROUBLESHOOT FOR HER HUSBAND'S HIGH BLOOD GLUCOSE. SHE ALSO REPORTED THAT HIS INSULIN PUMP HAD SEVERAL NO DELIVERY ALARMS FOR THE PAST TWO WEEKS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592630 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization