BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5003864 · Received August 14, 2015

    Report

    Report Number
    2032227-2015-29753
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING AND WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARMS WERE NOTED. THE DEVICE WAS ALSO RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER'S PARENT CALLED AND REPORTED THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015 WITH HIGH BLOOD GLUCOSE IN THE 300 TO 399 MG/DL RANGE AND DIABETIC KETOACIDOSIS. CUSTOMER EXPERIENCED THE SYMPTOM OF NAUSEA AND WAS TREATED WITH INSULIN AND ANTI-NAUSEA MEDICATION. THE CUSTOMER WAS THEN HOSPITALIZED AGAIN ON (B)(6) 2015 WITH HIGH BLOOD GLUCOSE OF 400 MG/DL AND DIABETIC KETOACIDOSIS. SHE EXPERIENCED VOMITING AND ABDOMINAL AND CHEST PAIN. CUSTOMER WAS TREATED WITH SALINE, INSULIN, AND ANTI-NAUSEA MEDICATION. SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. TROUBLESHOOTING WAS DECLINED. IT WAS ADVISED THE DEVICE WOULD BE REPLACED AND AGREED UPON THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538950 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization