BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4011672 · Received August 15, 2014

    Report

    Report Number
    2032227-2014-08418
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. THE MOTOR TESTED OKAY AND NO MOTOR ERROR ALARMS OR EXCESSIVE NO DELIVERY ALARMS WERE NOTED.

    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 RECEIVED A MOTOR ERROR WHILE DOING A BOLUS AND FIVE NO DELIVERY ALARMS PRIOR TO THE CALL. CUSTOMER STATED SHE HAD THE PUMP WHILE HAVING A CHEST X-RAY IN (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE WAS 115 MG/DL. ADVISED THE CUSTOMER TO DISCONTINUE USE AND REVERT TO BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490106 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR