BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201272 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42841
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM NOTED. ALL BUTTONS FUNCTIONING PROPERLY. NO DAMAGE IN KEYPAD ASSEMBLY NOTED. NO BUTTON ERROR ALARM NOTED. INSPECTED LCD CONNECTOR AND NO UNLOCKED CONNECTOR NOTED INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST, DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION TEST DUE TO PRIME ANOMALY. INSULIN PUMP DOWNLOADED PROPERLY TO THE CARELINK SOFTWARE NOTED. NO UPLOAD ANOMALY NOTED. THE TEST ULTRA LINK METER COMMUNICATES PROPERLY TO THE INSULIN PUMP. NO METER ANOMALY OR LINK ANOMALY NOTED. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE AND THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED BUTTON ERROR OCCURED WHICH EXPLAINS HER HIGH BLOOD GLUCOSE OF 600 MG/DL. CUSTOMER STATED THAT SHE DO NOT PAY ATTENTION TO THE INSULIN PUMP AND REFUSES TO DELIVER INSULIN WHILE AT SCHOOL. THE SECOND BUTTON ERROR ALARM, SHE WAS SITTING ON THE INSULIN PUMP SO BUTTONS WERE PRESSED FOR AT LEAST 3 MINUTES. CUSTOMER'S BLOOD GLUCOSE AT THAT TIME WAS 250 MG/DL. TROUBLESHOOTING WAS DONE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681451 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR