BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2893740 · Received January 2, 2013

    Report

    Report Number
    2032227-2012-08165
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. HOWEVER UNIT WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE, AND SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS 340 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization