BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4202172 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37162
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT INSULIN PUMP HAD A BLANK SCREEN. BLOOD GLUCOSE READING WAS 160 MG/DL. THE CUSTOMER CHANGED THAT BATTERY AND RECEIVED A BATTERY OUT LIMIT ALARM. CUSTOMER HAD A BLOOD GLUCOSE READING OF 40 MG/DL BEFORE BREAKFAST DUE TO HAVING A SMALL DINNER LAST NIGHT. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE IS CURRENTLY NORMAL. TROUBLESHOOTING WAS PERFORMED. A CRACK WAS FOUND ON THE DISPLAY SCREEN. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648943 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR