BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3990368 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91298
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WAS RECEIVED WITH A PRIME ALARM DURING BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP HAD CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN ALARM FOR A LOOSE DRIVE SUPPORT CAP. CUSTOMER WAS PREGNANT AND IN THE HOSPITAL FOR NEPHROPATHIA AT THE TIME OF THE REPORT. THE BLOOD GLUCOSE READING WAS 155 MG/DL. IT WAS REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER WAS UNABLE TO EXIT THE "PREPARING TO PRIME" LOOP. THE DRIVE SUPPORT CAP APPEARED NORMAL AND RECESSED AND THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464514 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1