BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP H

    MDR report key: 2870062 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08001
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY, OPERATING CURRENTS AND OFF NO POWER ALARM DUE TO MOTOR ERROR ALARMS. UNIT HAD MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLE, CRACKED TUBE THREADS AND LIP, CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT WAS RECEIVED WITHOUT ORIGINAL BELT CLIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS ABOVE 500 MG/DL. CALLER STATED THAT THE CUSTOMER WAS HAVING BATTERY PROBLEM WITH HER INSULIN PUMP PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP H OYC OYC MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization