BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4192913 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41757
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE TO PROTRUDED LOOSE DRIVE SUPPORT DISK. NO A33 ALARM. THE INSULIN PUMP MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP.

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT OF THE TUBING. CUSTOMER WOULD REWIND AND PRIME AGAIN, BUT THE SAME THING WOULD HAPPEN. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 234 MG/DL. CUSTOMER STATED THAT SHE WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THE REWIND MESSAGE OCCURRED AFTER AN ALARM/ALERT. CUSTOMER HAS DROPPED THE PUMP A FEW TIMES, BUT THERE ARE NO SIGNS OF DAMAGE. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673581 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR