BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4062112 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16545
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE READINGS OF 498 MG/DL AND STATED THAT THEY WERE TREATED WITH INSULIN DRIPS. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE READINGS WERE 55 MG/DL AND IS NOW CLIMBING UP TO 498 MG/DL. CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND LIGHT HEADEDNESS PRIOR TO THE HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP WAS NOTED TO BE NORMAL. CUSTOMER STATED THAT THERE WAS A CRACK ON THE SCREEN OF THE INSULIN PUMP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541767 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization