BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930835 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03766
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM BASIC OCCLUSION, PRIME/A33, THE EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. INSULIN PUMP RECEIVED WITH NO BACK LIGHT DUE TO FAULTY EL PANEL ON LCD BOARD. MINOR SCRATCHED DISPLAY WINDOW, CRACKED AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP NOTED.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A BACK LIGHT ANOMALY. CUSTOMER HAD ALREADY CHANGED THE BATTERY AND ITS STILL NOT WORKING. CUSTOMER ALSO MENTIONED THAT SHE HAS BEEN HAVING HIGHER BLOOD GLUCOSE LEVELS THAN NORMAL. CUSTOMER SAID IS NOT THE PUMP AND SHE KNOWS IT IS STRESS AND DOES NOT NEED TO TROUBLE SHOOTING. THE BLOOD GLUCOSE READING WAS 149 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408665 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR