BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141838 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32971
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP PASSED THE RESET ERROR TEST. NO UNEXPECTED RESET WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED A PRIME REWIND ALARM ON HER INSULIN PUMP, AND INSULIN WAS SQUIRTING OUT OF THE NEEDLE DURING THE MANUAL PRIME PROCESS. HER BLOOD GLUCOSE WAS 104 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER STATED SHE HAD HIT THE INSULIN PUMP AGAINST A COPIER. SHE ALSO STATED THE DRIVE SUPPORT CAP APPEARED NORMAL, AND THE CUSTOMER DID NOT PRESS THE CAP WHILE CONNECTED. SHE WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621599 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR