BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240360 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49489
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. NO DELIVERY ANOMALY WAS NOTED DURING TESTING. ALL BOLUSES WERE DELIVERED AND PROPERLY RECORDED IN BOLUS HISTORY. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE READING WAS 429 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721960 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR