BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894868 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03356
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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 WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE AT KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO FROZEN DISPLAY ANOMALIES. UNABLE TO PRIME INSULIN PUMP DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHED DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT HER INSULIN PUMP ISN'T WORKING. CUSTOMER STATED THAT WHEN SHE ATTEMPTED TO GIVE HERSELF A EASY BOLUS THE INSULIN PUMP JUST FROZE. THE CURRENT BLOOD GLUCOSE READING IS 129 MG/DL. INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370189 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR