BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWS

    MDR report key: 8643700 · Received May 27, 2019

    Report

    Report Number
    2032227-2019-07282
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    May 22, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000084332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ALARMED MOTOR ERROR DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME OR A33 TEST AND EXCESSIVE NO DELIVERY TEST OR VERIFY E70 DUE TO MOTOR ERROR ALARMS.

    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 THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AS WELL AS MULTIPLE MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVELS WAS 25 MMOL/L. THE CUSTOMER DID NOT PROVIDE DETAILS ON SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE LEVEL EPISODES. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED FOR INSULIN PUMP ERROR ALARM. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437427 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS B4722WWSJ 00763000084332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other