BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4170881 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37898
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-37897.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CALLER STATED THAT HE REWOUND WITH THE SAME RESERVOIR AND WAS ABLE TO DELIVERY THE BOLUS; HOWEVER, HE WAS UNSURE WHETHER HE RECEIVED THE BOLUS, SO HE TREATED WITH A MANUAL INJECTION AS WELL. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING. HE NOTED THAT HE HAD BEEN HAVING LEAKY RESERVOIRS RECENTLY. THE INFUSION SETS AND RESERVOIRS HAD BEEN DISCARDED, AND TROUBLESHOOTING FOR THE ISSUE COULD NOT BE DONE. THE CALLER STATED THAT HE WAS USING NEW SUPPLIES AND DID NOT HAVE ANY CURRENT ISSUES. HE NOTED THAT HE RESOLVED THE ISSUE ON HIS OWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649239 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1