BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAS PRDGM INSULIN PUMP

    MDR report key: 7920692 · Received September 28, 2018

    Report

    Report Number
    2032227-2018-35256
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR, PRIME ANOMALY AND REWIND ANOMALY. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS SQUIRTING INSULIN DURING PRIMING. THE INSULIN PUMP GRINDS DURING REWIND PROCESS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758914 NAS PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR