BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4213391 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-42912
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THERE MAY HAVE BEEN A PROBLEM WITH THE ACT BUTTON. THE BLOOD GLUCOSE READING WAS 255 MG/DL, WHICH THE CUSTOMER HAD ALREADY TREATED FOR, BUT SHE STATED THAT SHE HAD NOT GIVEN HERSELF A BOLUS FOR LUNCH. SHE STATED THAT SHE PROGRAMMED HER CARBOHYDRATES AND BLOOD GLUCOSE VALUE INTO THE INSULIN PUMP, THEN THOUGHT SHE HAD PRESSED THE ACT BUTTON BUT SHE DID NOT SEE A BOLUS IN HER BOLUS HISTORY. UPON TROUBLESHOOTING, THE CUSTOMER WAS ABLE TO SUCCESSFULLY PROGRAM AND DELIVER A 0.5 UNIT MANUAL BOLUS AND IT WAS RECORDED INTO THE HISTORY PROPERLY. SHE ALSO REPORTED NO DELIVERY ALARMS, WHICH HAD HAPPENED IN THE PAST, BUT DECLINED TROUBLESHOOT FOR THIS. ADVISED THE CUSTOMER THAT SHE MUST PRESS THE ACT BUTTON TO COMPLETE THE BOLUS OF 5.4 UNITS SHE HAD INTENDED TO DELIVER. ADVISED TO MONITOR THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680659 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR