BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 7688099 · Received July 13, 2018

    Report

    Report Number
    3004209178-2018-91558
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    December 1, 2017
    Report Date
    July 13, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. ALSO, MOISTURE DAMAGE MOTOR DURING VISUAL INSPECTION. UNABLE TO PERFORM OPERATING CURRENTS, SELF TEST, REWIND TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY.

    Description of Event or Problem · 1

    COMPLAINTS TEXT (B)(6) 2018, (B)(6), CUSTOMER STATES SHE RECEIVED A LETTER STATING THAT SHE STILL NEEDS TO RETURN PUMP. HOWEVER, (B)(4) FOUND THE TRACKING NUMBER AND I ADV TO DISREGARD LETTER. (B)(4). IT WAS DELIVERED ON FRIDAY (B)(6), COMPLAINTS TEXT (B)(6) 2017, (B)(6), CUSTOMER WAS TRANSFERRED AFTER TRYING TO CALL BACK. CUSTOMER REQUESTED THAT PUMP BE MAILED OUT TO ARRIVE ON (B)(6) 2017. BUT TO BE SAFE WE AGREED TO MAIL ON THE 26TH TO ARRIVE (B)(6) 2017 DUE TO UNKNOWN HOLIDAY SHIPPING HOURS. ORDER WAS RELEASED COMPLAINTS TEXT (B)(6) 2017, (B)(6) CALLED CUSTOMER AND LEFT VM TO RETURN CALL TO CONFIRM SHIPPING DETAILS FOR PUMP ORDER. COMPLAINTS TEXT (B)(6) 2017, ERP_RFC_USER RELATED (B)(4). COMPLAINTS TEXT (B)(6) 2017, (B)(6), ADD'L NOTES: CUSTOMER ALSO REQUEST PUMP AND BELT CLIP TO BE SHIPPED TO ALTERNATIVE ADDRESS ON TIME ONLY, EXPL RPL WILL BE SHIPPED WHENEVER IN STOCK AND SOMEONE WILL CONTACT HER TO VERIFY ADDRESS. (B)(6), COMPLAINTS TEXT (B)(6) 2017, (B)(6) INITIAL NOTES: CUSTOMER GOT IN THE POOL AND GOT OUT RIGHT BACK OUT BUT NOTICED FLUID BEHIND THE SCREEN INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER STS WENT TO THE POOL WITH THE PUMP DID NOT REALIZE THAT SHE WAS WEARING PUMP EXPOSED TO FLUID T/S PER (B)(4). CUSTOMER REPORTS THE TYPE OF FLUID/MOISTURE EXPOSURE TO THE PUMP IS: WATER. CUSTOMER REPORTS HOW THE FLUID/MOISTURE EXPOSURE OCCURRED IS: WAS IN THE POOL. CUSTOMER REPORTS THERE IS FLUID UNDER THE LCD DISPLAY. INQUIRED IF THE PUMP WAS DROPPED. CUSTOMER RESPONSE: WAS NOT DROPPED ON THE FLOOR. INQUIRED IF THERE ARE CRACKS OR OTHER ISSUES WITH THE PUMP. CUSTOMER RESPONSE: NOTHING, SOME FEW SPOT BEHIND THE SCREEN. ADV TO DISCONTINUE USE OF THE PUMP. ADV TO REVERT TO BACKUP PLAN PER HCP INSTRUCTION. EXPL RPL POLICY. EXPL INTERACTION AFTERCARE EMAIL. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: DID T/S DETERMINED PUMP TO BE RPL SHIP: MMT-751NAS / RETURN: MMT-751NAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527885 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A4751NASJ 00643169503717

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR