BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153436 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35151
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-35157.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED A LOW THRESHOLD SUSPEND ALERT ON THE INSULIN PUMP WHILE HER BLOOD GLUCOSE WAS 107 MG/DL AND THE SENSOR WAS GIVING A READING BELOW 40 MG/DL. SHE WAS ADVISED TO SELECT THE OPTION TO EITHER SUSPEND OR RESTART BASAL RATE INSULIN. THE CUSTOMER STATED SHE HAD BEEN SELECTING RESTART BASAL FOR THE ENTIRE DURATION OF THE NIGHT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630877 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR