BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233766 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48552
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    FINDINGS: 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 INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNIT ALSO 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. PENDING DVA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT IN (B)(6) THAT CAUSED HIM TO BE HOSPITALIZED. CUSTOMER SPENT 4 DAYS WHERE HE HAS NO MEMORY OF WHAT HAPPENED. CUSTOMER CALLED 911 AND CONTACTED LIFE ALERT, SO THE PARAMEDICS WERE CALLED. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF THE 911 CALL. CUSTOMER WAS ADVISED BY DOCTORS TO REPLACE THE PUMP. THE DOCTOR TOLD HIM THE PUMP WAS BROKEN. CUSTOMER COULD NOT WALK AND WAS UNAWARE OF THE DIAGNOSIS. CUSTOMER STATED THAT THE DOCTOR SAID THAT THE PUMP WAS JUST OUT OF INSULIN. CUSTOMER HAS BEEN OFF THE PUMP SINCE THE (B)(6) INCIDENT. CUSTOMER HAD A DOCTOR'S APPOINTMENT ON (B)(6) 2014 TO SET UP GETTING BACK ON THE PUMP. CUSTOMER STATED THAT THE ACT BUTTON WAS NOT WORKING. CUSTOMER HAS BEEN BACK IN THE HOSPITAL TWICE SINCE THE INCIDENT IN (B)(6). CUSTOMER WAS NOT SURE IF HE WAS HOSPITALIZED FOR HIGH OR LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL TODAY WAS 130 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714607 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization