BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4130716 · Received September 30, 2014

    Report

    Report Number
    2032227-2014-05912
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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. NO BUTTON ERROR ALARMS WERE NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS NOTED ON THE KEYPAD TRACES.

    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 IS REPORTED BY THE MOTHER OF THE CUSTOMER THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 300 MG/DL. THE MOTHER OF THE CUSTOMER REPORTED A BUTTON ERROR ALARM COMING FROM THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. THE CUSTOMER WAS FURTHER ADVISED TO CONTACT HER HEALTH CARE PROFESSIONAL TO CHECK THE BASAL RATES. ADVISED THE CUSTOMER TO REMOVE THE BATTERIES FROM THE INSULIN PUMP. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607228 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1