BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143429 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30069
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. UNIT RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. 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

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 630 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER DECLINED ANY TROUBLESHOOTING AND WILL CALL BACK TO TROUBLESHOOT IF ISSUES PERSISTS AFTER PUMP REPLACEMENT. CUSTOMER STATED THAT THE HOSPITALIZATION WAS ON (B)(6) 2014 SINCE CUSTOMER'S BLOOD GLUCOSE INCREASED FORM 200 MG/DL AT HOME AND WITHIN A FEW HOURS BLOOD GLUCOSE LEVELS WENT OVER 600 MG/DL. CUSTOMER WAS TREATED VIA INSULIN DRIP. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF HOSPITALIZATION. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603556 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization