BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5228043 · Received November 16, 2015

    Report

    Report Number
    2032227-2015-66379
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    July 8, 2013
    Report Date
    November 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT RECEIVED NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. UNIT RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP. UNIT RECEIVED WITH CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER. UNIT RECEIVED MISSING ENDCAP STICKER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. THE CUSTOMER IS UNABLE TO CLEAR THE ALARM. THE CUSTOMER PUMP IS OOE AND RETURNED TO BE SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758132 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1