BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200576 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42729
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. NO BLANK DISPLAY NOTED. NO DAMAGE FOUND ON THE LCD CONNECTOR ISOLATION TAPE NOTED. INSULIN PUMP RECEIVED WITH MOISTURE DAMAGE NOTED ON ELECTRONICS ASSEMBLY. INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN HAS A BLACK DISPLAY AFTER 4 BATTERY CHANGES AND NO ALARMS OCCURRED PRIOR. IT WAS STATED THAT THE INSULIN PUMP DOES NOT HAVE PHYSICAL DAMAGE. THE DEVICE MIGHT HAVE BEEN EXPOSED TO MOISTURE FROM WORKING OUT; HE USES BELT CLIP WITH POUCH. THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED AND THE BATTERY COMPARTMENT IS NOT DAMAGED OR CORRODED. CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY; THE DISPLAY DID NOT RETURN. THEN HE WAS INSTRUCTED TO REMOVE THE BATTERY FOR 10 MINUTES, CLEAN THE BATTERY CAP AND REINSERT THE BATTERY; DISPLAY DID NOT RETURN. BLOOD GLUCOSE VALUE IS 157 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678868 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR