BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972423 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05202
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCH ON THE ACT BUTTON. NO BUTTON ERROR ALARM, NO RAMPING NUMBERS, OR SCROLL BAR MOVING ON ITS OWN NOTED. INSULIN PUMP RECEIVED WITH SEVERELY SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND SCRATCHED AROUND CASING.

    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

    THE CUSTOMER REPORTED A BUTTON ERROR ALARM. THE BLOOD GLUCOSE READING WAS 130 MG/DL. THERE WERE NO SIGNIFICANT EVENTS THAT LED TO THE EVENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446443 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR