BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 8909450 · Received August 20, 2019

    Report

    Report Number
    2032227-2019-49276
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    August 7, 2019
    Report Date
    December 29, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169404342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO REWIND ANOMALIES NOTED. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. "ANALYSIS MEETS SPECIFICATION" Y. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS LAST COMPLETED DATE WAS NOVEMBER 12, 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS LAST COMPLETED DATE WAS NOVEMBER 12, 2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT DIFFERENT SOUND DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704060 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A2751NASJ 00643169404342

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR