BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3251170 · Received July 29, 2013

    Report

    Report Number
    2032227-2013-03158
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 27 MG/DL. CUSTOMER STATED THAT HE HAD A SEIZURE DUE TO LOW BLOOD GLUCOSE PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352753 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization