BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4002379 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-91658
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED ONE OPENED/USED RESERVOIR. INSPECTED RESERVOIR, SNAP-CAP, AND SEPTUM FOR ANOMALIES. NONE WERE FOUND. RAN OCCLUSION TEST AS FOLLOWS: THE RESERVOIR WAS FILLED WITH DILUENT AND CONNECTED TO A NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO AN INSULIN PUMP. PERFORMED THE MANUAL PRIME, AND VISUAL FLUID DID FLOW THROUGH THE INFUSION SET AND OUT CATHETER TIP. THE RESERVOIR WAS 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

    CUSTOMER'S MOTHER REPORTED THAT THE INSULIN PUMP WOULD NOT BE REWOUND. SHE STATED THAT THERE HAD BEEN AN OFF NO POWER ALERT AND WAS ADVISED THAT THE INSULIN PUMP NEEDED A BATTERY CHANGE BEFORE REWINDING BECAUSE, IT WAS IN A LOW BATTERY STATE. SHE WAS NOT SURE WHAT THE BLOOD GLUCOSE READING WAS. THERE WAS NO LOW BATTERY ALERT THAT OCCURRED BEFORE THE OFF NO POWER ALERT. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED. SHE ALSO REPORTED A NO DELIVERY ALARM, WHICH HAD BEEN RESOLVED BY A COMPLETE SET CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480090 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG03LDE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR