BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4131857 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31501
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, AND BASIC OCCLUSION TEST. HOWEVER, THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE PRIME TEST DUE TO A MOTOR ENCODER SIGNAL OUT OF PHASE. THE INSULIN PUMP BUTTONS ALL RESPONDED PROPERLY AND NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM AND A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 255 MG/DL. CUSTOMER RECEIVED AN ALARM WHEN HE WAS USING A BOLUS. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER WAS ASSISTED WITH FINDING ALL OF HIS BASAL/BOLUS WIZARD/FIXED PRIME SETTINGS. CUSTOMER WAS ADVISED TO RETURN THE PUMP WITH THE BATTERY AND ZERO OUT THE BASAL RATES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER ALSO STATED THAT HE HAD A BUTTON ERROR WHEN THE ALARM HISTORY WAS REVIEWED. IN ADDITION, CUSTOMER STATED HE HAD A BUTTON ERROR AND HIS BLOOD GLUCOSE LEVEL WAS 309 MG/DL. CUSTOMER DID NOT KNOW IF THE BUTTON WAS HELD DOWN FOR THREE MINUTES. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613047 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR