BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4842601 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-65118
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY 3 TO 4 TIMES WITHIN THE LAST MONTH. SHE STATED THAT SHE WOULD RECEIVE THE ALARM SEVERAL HOURS AFTER A SET CHANGE. SHE WAS ADVISED THAT IT TAKES SEVERAL HOURS FOR PRESSURE TO BUILD ENOUGH TO TRIGGER THE ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 416 MG/DL. THE CUSTOMER CHANGED THE ENTIRE SET AND BLOUSED. THE CUSTOMER REPORTED THAT THE ALARM WAS RESOLVED BY A COMPLETE SET CHANGE AND DECLINED TO RETURN THE INFUSION SET AND RESERVOIR FOR ANALYSIS. THE CUSTOMER DECLINED TO DO ANY FURTHER TROUBLESHOOTING AND WAS ADVISED TO CALL WHEN THE ISSUE OCCURRED BEFORE THE SET CHANGE IN ORDER TO BETTER DETERMINE THE CAUSE OF THE NO DELIVERY ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384511 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR