BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143031 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30087
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE HAD AN EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE AND HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE AT TIME OF EMERGENCY ROOM VISIT WAS 600MG/DL. DURING TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE IT WAS FOUND THAT CANNULA WAS SLIGHTLY BENT. CUSTOMER STATES DUE TO HER LOSING HER JOB, SHE IS NOT ABLE TO PURCHASE SUPPLIES. CUSTOMER WAS ADVISED THAT EMERGENCY SUPPLIES WOULD BE SENT TO HER. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603518 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization