BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143014 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29955
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED SOFTWARE ERROR DUE TO DOWNLOAD ERROR. WILL REMOVE BATTERY FOR A PERIOD OF 20 AND 30 TO INIZILIZED THE FUNCTION PROPERLY.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. NO UNEXPECTED ALARMS NOTED. HOWEVER, THE INSULIN PUMP HAD MULTIPLE ALARMS IN ALARM HISTORY SCREEN. THE INSULIN PUMP ALARMED DUE TO CORRUPTED HISTORY FILE. THE INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF 44MG/DL. IT WAS ALSO REPORTED THAT THE CUSTOMER'S INSULIN PUMP RECEIVED A SOFTWARE ERROR ALARM. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603513 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR