BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243990 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50372
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY ALARM TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM OR UNEXPECTED NO DELIVERY ALARMS WERE NOTED. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A SLIGHTLY LOOSE DRIVE SUPPORT DISK, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE AND TUBE LIP AND WINDOW, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT THE CUSTOMER HAD A MOTOR ERROR ALARM AND A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER'S MOTHER STATED THAT THE CUSTOMER'S KETONES ARE HIGH AND THAT SHE HAS CHANGED HER INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 480 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE PUMP. CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. HELPLINE WAS UNABLE TO TROUBLESHOOT FOR THE NO DELIVERY ALARM SINCE THE CUSTOMER HAD ALREADY CHANGED THE INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725700 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR