BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193629 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41323
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE HIGH BLOOD GLUCOSE OF 400 MG/DL, WHICH WAS TREATED WITH A BOLUS DELIVERY. TROUBLESHOOTING WAS PERFORMED ON INSULIN PUMP TO DETERMINE REASON FOR HIGH BLOOD GLUCOSE. TROUBLESHOOTING COULD NOT BE COMPLETED AS CUSTOMER DID NOT HAVE TUBING CLAMP. CUSTOMER WAS ADVISED THAT TUBING CLAMP WOULD BE SENT TO HER AND TO CALL BACK UPON RECEIPT IN ORDER TO COMPLETE TROUBLESHOOTING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672019 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention