BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5253322 · Received November 28, 2015

    Report

    Report Number
    2032227-2015-69387
    Event Type
    Malfunction
    Date Received
    November 28, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO A44 ALARM NOTED AND PASSED SELF TEST. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL MULTIPLE IOP TEST FAILURE ALARMS ON THE INSULIN PUMP. CUSTOMER ADVISED THEY RECEIVED THE ALARM TWICE DURING A BASAL ATTEMPT. TROUBLESHOOTING FOR THE ALARM WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783198 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR