BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5347123 · Received January 6, 2016

    Report

    Report Number
    3004209178-2016-80304
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    December 19, 2015
    Report Date
    December 21, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED AND TESTED WITH NO BLANK DISPLAY AND NO LOW BATTERY ALARM NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES AND SEVERELY SCRATCHED DISPLAY WINDOW NOTED. THE INSULIN PUMP PASSED ALL OPERATING CURRENTS TESTED WITHIN THE SPECIFICATION RANGE AND PASSED OFF NO POWER TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF A BLANK DISPLAY FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 132-190 MG/DL. THE CUSTOMER STATED THAT HE RECEIVED A LOW BATTERY ALARM WHEN HE SWITCHED OUT THE BATTERY. THE CUSTOMER STATED THAT HE TRIED TO BOLUS AND THE PUMP DIED OUT AFTER THAT. THE CUSTOMER STATED THAT THERE IS A U SHAPED CRACK WHERE THE BATTERY CAP IS ON THE PUMP. THE CUSTOMER STATED THAT HE DROPPED THE PUMP OUT OF HIS PANTS. THE CUSTOMER STATED THAT HE DROPPED HIS PUMP AT LEAST ONCE A DAY WHEN HE WAKES UP IN THE MORNING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WILL BE SENT A REPLACEMENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6827 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR