BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143059 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29876
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. UNIT PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNIT HAD CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 545 MG/DL. CUSTOMER REPORTED BEING TREATED WITH AN INSULIN DRIP. CUSTOMER STATED THAT SHE WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER REPORTED HAVING A HIGH BLOOD GLUCOSE LEVEL OF 145 MG/DL THE NIGHT BEFORE THE HOSPITALIZATION THAT KEPT RISING. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603570 PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization