BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3093679 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01659
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME AND THE EXCESSIVE NO DELIVERY TEST DUE TO BUTTON/KEYPAD ANOMALY. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER CALLED AND ADVISED HELP LINE THAT HER MOTHER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. REQUESTED THAT HELP LINE CUSTOMER. CUSTOMER STATED THAT HER BLOOD GLUCOSE READING AT TIME OF 911 CALL WAS 526 MG/DL. THE CURRENT READING IS 447 MG/DL. THE CUSTOMER IS BEING TREATED WITH LANTUS. CUSTOMER HAD A HARD TIME BREATHING, POSSIBLE CONGESTIVE HEART FAILURE. UNABLE TO TROUBLESHOOT, THE INSULIN PUMP HAD BUTTON ERROR, UNABLE TO CLEAR ALARM. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196443 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization