BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183508 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40248
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS NOTED DURING TESTING. HOWEVER, THE DEVICE WAS RECEIVED WITH SLIGHTLY LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE MOTOR ERROR ALARMS HAVE BEEN HAPPENING FOR THE LAST COUPLE OF WEEKS. CUSTOMER STATED THAT ALARM OCCURRED DURING THE BOLUS AND PRIME. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE PUMP. CUSTOMER STATED THAT HE WAS ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO RETURN THE PUMP WITH THE BATTERY AND TO ZERO OUT THE BASAL RATES. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663858 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 61 YR