BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3120938 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93692
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    MOTOR ERROR ALARMS DURING OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. THE INSULIN PUMP PASSED THE PRIME, BASIC OCCLUSION, NO DELIVERY AND DISPLACEMENT TESTS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING IS 510 MG/DL. CUSTOMER HAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT HE IS NAUSEATED. HCP RECOMMENDED THAT THE INSULIN PUMP GETS REPLACED. HCP TRIED CHANGING THE BASAL SETTING, THE BLOOD GLUCOSE READING WOULD NOT DECREASE. EXPLAINED TO CALLER THAT IT TAKES TIME FOR THE BASAL TO ADJUST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222359 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization