BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182618 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39701
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE, LOW BLOOD GLUCOSE AND THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED HE WAS TRYING TO GIVE BOLUS FOR THE HIGH BLOOD GLUCOSE AND GOT BUTTON ERROR. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. CUSTOMER STATED THE INSULIN PUMP COULD HAVE GOTTEN TO MOISTURE DUE TO SWEAT. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 45 MG/DL WHEN HE WOKE UP. HE ATE AND TOOK GLUCOSE TABLETS. UNABLE TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE DUE TO BUTTON ERROR. 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
    660951 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR