BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972175 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05126
    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
    GA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. ALSO RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AND SCRATCHED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A LOW RESERVOIR ALARM ON THE INSULIN PUMP. HE STATED THAT THE ALARM COULD NOT BE CLEARED BY PRESSING THE ESCAPE OR THE ACT BUTTON. THE BLOOD GLUCOSE READING WAS 298 MG/DL. HE TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE NOT RESPONSIVE. NOTHING FURTHER WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447481 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR