BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3945189 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04605
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    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 PATIENT STATED THAT THE PUMP ALARMED BUTTON ERROR, AND DELIVERED TOO MUCH INSULIN. THE PATIENT STATED THAT SHE WAS PRIMING THE PUMP, AND NOTICED THAT THE NUMBER OF UNITS ON THE SCREEN REACHED 29. THE PATIENT TOOK THE PUMP OFF, AND THEN IT GAVE A BUTTON ERROR ALARM, AND THE ACT BUTTON STOPPED RESPONDING. THE REPORTED BG AT THE TIME OF THE CALL WAS 230 MG/DL. ADVISED THE PATIENT THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422634 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR