BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-551NAP

    MDR report key: 8806150 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32468
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE HARDER TO PUSH. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP REJECTED NEW BATTERY. INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING PRIMING. INSULIN PUMP WAS LOUDER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602165 530G INSULIN PUMP MMT-551NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP A4551NAPJ 00643169503656

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR