BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8711343 · Received June 19, 2019

    Report

    Report Number
    2032227-2019-18358
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 1, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH CRACKED DISPLAY WINDOW CORNERS AND CRACKED BATTERY TUBE THREADS NOTED. THE TEST RESERVOIR P-CAP WAS ABLE TO LOCK IN PLACE. DEVICE PASSED DISPLACEMENT TEST. HOWEVER DEVICE ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO VERIFY POSSIBLE UNDER DELIVERY ANOMALY OR PERFORM PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT ACCURACY TEST, A21 ERROR TEST AND OCCLUSION TEST DUE TO MOTOR ERROR. DEVICE PASSED SELF TEST, OFF NO POWER TEST AND ALL OPERATING CURRENTS TESTED WITHIN THE SPECIFICATION. DEVICE WAS DOWNLOADED TO CARELINK PRO PROPERLY.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER'S BLOOD GLUCOSE WAS 240, 220, 250 MG/DL. THE INSULIN PUMP WAS CRACK ON THE BACK OF THE INSULIN PUMP. THE TROUBLESHOOTING WAS PERFORMED FOR THE DAMAGE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505328 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH B5723NAHJ 00643169507227

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR