BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4210631 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43268
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OP CO
    Product Code
    OZO
    PMA / PMN Number
    P120010
    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 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 (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 BECAUSE OF HIGH BLOOD GLUCOSE LEVEL. SHE REPORTED HER BLOOD GLUCOSE LEVEL TO BE 581 MG/DL AT THE TIME OF HOSPITALIZATION. AT THE TIME OF THE REPORT HER BLOOD GLUCOSE LEVEL WAS 385 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP TO PERFORM TROUBLESHOOTING AND THE PUMP WAS WORKING PROPERLY. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680658 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OP CO MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other