BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4240507 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49723
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR WAS OCCLUDED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS ATTEMPT. THE BLOOD GLUCOSE READING WAS 205 MG/DL. HE STATED THAT HE CHANGED THE INFUSION SET. UPON TROUBLESHOOTING, INSULIN DID NOT EXIT DURING A FIXED PRIME AND THE DEVICE ALARMED NO DELIVERY. INSULIN DID, HOWEVER, EXIT THE TUBING DURING A PLUNGER PUSH. INSULIN EXITED DURING THE MANUAL PRIME, AND THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. ADVISED THE CUSTOMER THAT THE ALARM WAS CAUSED BY AN INFUSION SET OR RESERVOIR OCCLUSION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723457 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG063NR

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR