BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4871435 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-68932
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST PER SPECIFICATIONS, RESERVOIR FILLED AND CONNECTED TO NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO INSULIN PUMP AND PERFORMED INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR TO INSULIN PUMP AND PERFORMED CATHETER TIP. RESERVOIR NOT OCCLUDED.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE RECEIVED MULTIPLE NO DELIVERY ALARMS ON THE INSULIN PUMP. THE CUSTOMER STARTED TROUBLESHOOTING DURING AN EARLIER CALL, AND RECEIVED A NO DELIVERY ALARM DURING MANUAL PRIMING. THE CUSTOMER WAS UNABLE TO GET INSULIN TO EXIT THE TUBING. AFTER A SET CHANGE, THE CUSTOMER WAS ABLE TO USE THE PLUNGER TO GET INSULIN TO EXIT THE TUBING, BUT THEN RECEIVED ANOTHER NO DELIVERY ALARM DURING MANUAL PRIMING. AFTER AN ADDITIONAL SET CHANGE, THE CUSTOMER WAS ABLE TO GET INSULIN TO EXIT THE TUBING. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 255 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INFUSION SETS WOULD BE REPLACED, AND WILL RETURN THE PRODUCTS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414166 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG0A1U6

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR