BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930866 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03725
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    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 CALLED IN TO REPORT THAT HER KEYPAD WAS NOT RESPONDING AND THAT HER INSULIN PUMP WAS RECEIVING A BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 153 MG/DL. THE CUSTOMER STATES THE ISSUE WITH THE KEYPAD BEGAN WHEN SHE FOUND THE INSULIN PUMP WAS PRESSED AGAINST HER SKIN INSIDE HER WAIST BAND. WE ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE PUMP AND TO REVERT TO A BACK UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408593 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR