BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103799 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26571
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW AND A STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 479 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. SHE EXPRESSED SYMPTOMS OF THIRST, NAUSEA, HEADACHE AND URINATION. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. SHE FOUND NO AIR IN THE TUBING AND NO LEAKS. SHE WAS ADVISED TO RUN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT. SHE STATED THAT THE BASAL RATES WERE CORRECT. THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. SHE REMOVED THE INFUSION SET AND STATED THAT THE CANNULA WAS NOT BENT BUT THAT THERE WAS BLOOD AT THE SITE. SHE STATED THAT THE SITE WAS NOT SORE OR IRRITATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584602 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention