BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211841 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44858
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: THE DOWNLOAD HISTORY FILE SHOWS ON 09/26/14 AT 20:11 A NORMAL BOLUS OF 25.0 UNIT WAS PROGRAMMED AND DELIVERED. THE DOWNLOAD HISTORY FILE SHOWS NO 25.0 UNIT BOLUS AT 8 AM ON (B)(6) 2014. THE BUTTON EVENT FILE WAS OVER WRITTEN. UNABLE TO VERIFY IF CUSTOMER MANUALLY PROGRAMMED THE 25.0UNIT BOLUS. UNIT ALARMED BUTTON ERROR AND HAD NO BUTTON RESPONSE ON ACT BUTTON DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST OR TEST FOR BOLUS ANOMALY DUE TO NO BUTTON RESPONSE. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW AND BROKEN RESERVOIR TUBE LIP. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 30 MG/DL. THE CUSTOMER HAD A BUTTON ERROR ALARM ON INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP. THE CUSTOMER STATED THAT HE DOES NOT HAVE THE INSULIN PUMP AT THE MOMENT. THE CUSTOMER WILL BACK WHEN HE HAD THE INSULIN PUMP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692079 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization