BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWL

    MDR report key: 8685810 · Received June 11, 2019

    Report

    Report Number
    2032227-2019-14173
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 30, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00613994401991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE DISPLACEMENT TEST BUT MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM.

    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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 258 MG/DL AT THE TIME OF INCIDENT. DRIVE SUPPORT CAP WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482998 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWL B2722WWLJ 00613994401991

    Patients

    Seq Age Sex Outcome Treatment
    1