BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7559715 · Received June 1, 2018

    Report

    Report Number
    3004209178-2018-75923
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 11, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE DELIVERY ACCURACY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. NO BOLUS DELIVERY ANOMALY NOTED DURING TESTING.

    Additional Manufacturer Narrative · 1

    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 THEY WENT HOSPITAL DUE TO HIGH BLOOD GLUCOSE OF 350 MG/DL ON (B)(6) 2018. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 201MG/DL. CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS 227 MG/DL. CUSTOMER HAD SYMPTOMS SUCH AS NOURISH. DRIVE SUPPORT CAP WAS NORMAL. THERE WAS NO LEAK AND AIR BUBBLE. CUSTOMER WAS ALLEGING FOR UNDER DELIVERING BECAUSE BLOOD GLUCOSE WAS NOT RESPONDING TO THE BOLUS WHICH HE GAVE. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 240, 190, 287, MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402795 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A5723LNASJ 00643169513914

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other