BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4110508 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-26941
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO LOOSE AND PROTRUDED DRIVE SUPPORT DISK. INSULIN PUMP WAS UNABLE TO CONFIRM EXCESSIVE NO DELIVERY ALARM AND EMPTY RESERVOIR ALARM DUE TO MOTOR ERROR ALARMS. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, BLEEDING LCD GLASS, LOOSE AND PROTRUDED DRIVE SUPPORT DISK, SCRATCHED RESERVOIR WINDOW, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT HE WOULD GET A NO DELIVERY ALARM. CUSTOMER ALSO STATES THAT THE DRIVE SUPPORT CAP IS STICKING OUT. THE BLOOD GLUCOSE READING IS 138 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592007 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR