BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221460 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46638
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 1, 2013
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. NO FAILED BATTERY TEST ALARM NOTED. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH OUT ORIGINAL BATTERY CAP. UNIT ALSO RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS. (B)(4). A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER HAS PHYSICAL DAMAGE IN THE FORM OF CRACKS AND MISSING PIECES ON THEIR INSULIN PUMP AFTER TRYING TO TAKE THE BATTERY CAP OFF. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 250 MG/DL. THE CUSTOMER ALSO STATES THAT THERE WAS A HOSPITALIZATION IN AUGUST WITH A BLOOD GLUCOSE LEVEL OVER 500 MG/DL AT THE TIME OF ADMISSION. CUSTOMER STATED THEY WERE HOSPITALIZED FOR THEIR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701310 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization