BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP

    MDR report key: 10095149 · Received May 28, 2020

    Report

    Report Number
    2032227-2020-123241
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPECIFICATION AND PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, A21 ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO POSSIBLE UNDER DELIVERY ANOMALY NOTED. DEVICE WAS DOWNLOADED TO CARE LINK PRO PROPERLY AND ALL BOLUS DELIVERED WERE FOUND AT THE CARE LINK REPORT. DEVICE PASSED THE DELIVERY ACCURACY TEST AT 0.0873 INCHES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 455 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER DID BOLUS STILL CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 140, 301, 331, 317,362, 319, 315, 180, 179, 205 AND 291 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DECLINED TO CHECK AIR BUBBLES AND LEAK. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-UNK, UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562677 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAP A1523RNAPJ 00643169513082

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR