BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233080 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48645
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THE TUBING ON THE INFUSION SET BREAKING OFF. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS, BUT THE CUSTOMER DECLINED TROUBLESHOOTING BECAUSE THE HIGH BLOOD GLUCOSE LEVELS OCCURRED IN (B)(6) 2013. CUSTOMER STATED THERE WERE SCRATCHES ON THE PUMP, BUT SHE CAN READ THE PUMP AND DOES NOT NEED IT TO BE REPLACED. CUSTOMER STATED THAT THE KITCHEN COUNTER MOST LIKELY SCRATCHED IT. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. CUSTOMER IS FINE NOW AND STATED THAT THIS ISSUE WAS FROM LAST DECEMBER AND SHE HAS NOT HAD ANY ISSUES SINCE. CUSTOMER ORIGINALLY CALLED FOR ISSUES WITH THE CLIP AND INFUSION SETS, BUT WAS DISCONNECTED. CUSTOMER WAS USING A SCREEN PROTECTOR FROM THE PHONE FOR HER PUMP BECAUSE IT GETS NICKED SOMETIMES AND SHE WANTS IT PROTECTED. CUSTOMER STATED THAT THE SCREEN ON THE PUMP IS VERY SENSITIVE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715985 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR