BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183469 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40207
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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.

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND NO UNEXPECTED FAILED BATTERY TEST ALARMS WERE NOTED. HOWEVER, A CORRODED BATTERY CAP CONTACT WAS NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE ON THE RESERVOIR TUBE, A CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER A PUMP AND THE BATTERY CASING WAS CRACKED. CUSTOMER STATED THAT THE PUMP WILL NOT WORK AND THAT SHE IS GETTING A BATTERY A BATTERY FAILURE ALARM. CUSTOMER STATED THAT SHE WENT BACK TO HER OLD PUMP ON (B)(6) 2014. CUSTOMER NOTICED THE CRACK ON THE NEW PUMP ON (B)(6) 2014. CUSTOMER STATED THAT IT WAS PROBABLY WEAR AND TEAR ON THE PUMP. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663844 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR