BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL

    MDR report key: 6635336 · Received June 12, 2017

    Report

    Report Number
    3004209178-2017-54711
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    April 18, 2017
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST AND REWIND TEST. NO UNEXPECTED LOW BATTERY ALARM NOTED. THE BATTERY ICONS FUNCTIONED PROPERLY. NO BATTERY ICON ANOMALY NOTED. PUMP WAS TESTED WITH LIQUID FILLED RESERVOIR AND NO AIR BUBBLE ANOMALY NOTED. PUMP HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE DURING THE WEEK OF THE CALL. BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 400 MG/DL AND 237 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER TREATED WITH THE INSULIN PUMP. SHE STATED THAT BLOOD GLUCOSE LEVEL WAS 135 MG/DL IN THE MORNING AND THEN IT ROSE TO 243, 245, 276 AND 269 MG/DL. LAST INFUSION SET WAS ON THE MORNING OF (B)(6) 2017. TROUBLESHOOTING WAS PERFORMED AND NO ISSUES WERE FOUND WITH THE SITE, SET OR INSULIN. THE CUSTOMER DECLINED TO CHECK THE SETTINGS. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. THE CUSTOMER ALSO REPORTED RECEIVING MULTIPLE LOW BATTERY ALERTS. SHE STATED SHE HAD TO CHANGE THE BATTERY 3 TIMES IN ONE WEEK. IT WAS ADVISED THE DEVICE WOULD BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414104 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL B4523NALJ 00643169507180

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other