BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982320 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06171
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES HOWEVER, NO BUTTON ERROR ALARM NOTED. DURING VISUAL INSPECTION, MOISTURE DAMAGE TO ELECTRONIC AND MOTOR ASSEMBLIES WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LIQUID CRYSTAL DISPLAY WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNERS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR, HE TOOK OUT BATTERY AND THE ALARM STILL OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS 346 MG/DL, TREATED WITH MANUAL INJECTIONS. CUSTOMER REPORTED HE WAS AT THE BEACH AND A WAVE TOOK HIM UNDER AND PUMP WAS EXPOSED TO WATER; AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456593 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR