BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4230934 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48310
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. THE PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACE. THE PUMP ALSO HAD MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE PROCESS OF UPGRADING HER PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 51 MG/DL. CUSTOMER STATED THAT THE BUTTONS WERE STICKING AND THAT SHE WAS HAVING TROUBLE REWINDING THE PUMP. CUSTOMER STATED THAT SHE MAY HAVE CORRECTED EARLIER FOR A BLOOD GLUCOSE LEVEL OF 386 MG/DL. CUSTOMER ATE SOMETHING TO CORRECT IT. CUSTOMER STATED THAT THE BUTTON ISSUE STARTING HAPPENING 4 TO 6 MONTHS AGO. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH/LOW BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT SHE HAS A SERVICE DOG THAT ALERTS HER WHEN HER BLOOD GLUCOSE GOES LOW. CUSTOMER ALSO MENTIONED THAT SHE WAS UNABLE TO EXIT THE PREPARING TO PRIME SCREEN. CUSTOMER WAS UNABLE TO TROUBLESHOOT SINCE SHE IS NOT CURRENTLY PRIMING THE PUMP. CUSTOMER STATED THAT THIS HAPPENS AT LEAST ONCE A MONTH. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713804 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR