BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972187 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05210
    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
    FL
    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

    THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM PRIME TEST DUE TO MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. THE INSULIN PUMP WAS RECEIVED WITH SEVERELY SCRATCHED DISPLAY WINDOW AND A BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT DETECT THE RESERVOIR AND THAT THE PISTON CONTINUED TO PUSH WITH NO NUMBERS SCROLLING ON THE SCREEN. HE STATED HE WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS OR NUMBERS ON THE DISPLAY, AND HE STATED THAT HE DID NOT RECEIVE EITHER OF THESE. THE BLOOD GLUCOSE READING WAS 182 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447489 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR