BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS

    MDR report key: 8958747 · Received September 4, 2019

    Report

    Report Number
    2032227-2019-56429
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169202399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4). INITIAL NOTES: PATIENT REPORTING CRACK ON THE PUMP INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: PATIENT WAS JUST WEARING THE PUMP AND JUST WOKE UP BUMPED/DROPPED/COSMETIC DAMAGE T/S PER (B)(4). ADV TO D/C FROM THE PUMP. TYPE OF DAMAGE: CRACK. LOCATION OF THE DAMAGE: RESERVOIR . HOW DAMAGE OCCURRED: PT GOT NO IDEA. CUSTOMER REPORTS DAMAGE TO THE PUMP. IS THE PHYSICAL DAMAGE TO THE PUMP'S RESERVOIR LIP RING: YES ADV TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HCP'S INSTRUCTION. ADV THE PUMP WILL NEED TO BE REPLACED. EXPLAINED THE OOW RPL POLICY. REVIEWED PUMP CARE BEST PRACTICES WITH THE CUSTOMER. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: FOR PUMP REPLACEMENT - OOW ADVISED ABOUT SHIPMENT PATIENT UNDERSTOOD. **PT DECLINED TO RETURN THE PUMP.** SHIP: 1-PUMP / RETURN: 1-PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752584 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS B2723NASJ 00643169202399

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR