BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141839 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32972
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. INSULIN PUMP WAS UNABLE TO VERIFY PRIME ALARMS DUE TO MOTOR ERROR ALARMS. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON LCD WINDOW.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE RECEIVED A MOTOR ERROR ALARM, FOLLOWED BY A PRIME REWIND ALARM ON HIS INSULIN PUMP. THE MOTOR ERROR ALARM OCCURRED DURING A PRIMING ATTEMPT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 62 MG/DL, WHICH HE TREATED WITH JUICE. IT WAS STATED THAT THE INSULIN PUMP WAS NEITHER BUMPED NOR DROPPED PRIOR TO THE PRIME REWIND ALARM OCCURRING. WHILE TROUBLESHOOTING, THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS INDENTED AND NOT LOOSE. HE WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621714 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR