BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143046 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29845
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 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
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TEST. DEVICE HAD INTERMITTENT BUTTON RESPONSE NOTED DURING TESTING DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. DEVICE RECEIVED WITH CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS IN THE HOSP BECAUSE OF A LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING AND CUSTOMER ATTEMPTED TO TREAT HERSELF BUT DID NOT HAVE ANY LONG ACTING INSULIN AND GAVE HERSELF TOO MUCH FAST ACTING INSULIN. CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE BUTTONS WERE NOT RESPONDING. CUSTOMER WAS STAYING WITH A FRIEND WHO FOUND HER UNCONSCIOUS AND CALLED 911. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603519 PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization