BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4022218 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-95743
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING AN INSULIN BOLUS DELIVERY. CUSTOMER STATED HE DISCONNECTED AND REMOVED THE RESERVOIR AND THEN PUT THE ERASER END OF A PENCIL INTO THE RES TO USE AS A PLUNGER BUT INSULIN DID NOT COME OUT. BLOOD GLUCOSE IS 324 MG/DL. DURING TROUBLESHOOT; CUSTOMER PERFORMED A 5.0 UNIT FIXED PRIME; INSULIN DID EXIT AND INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER DID NOT HAVE A PLUNGER AVAILABLE. ADV TO REMOVE THE RESERVOIR FROM THE PUMP, DISCONNECT AND RECONNECT THE INFUSION SET AND THE RESERVOIR AND SLOWLY PUSH INSULIN THROUGH THE TUBING; INSULIN EXITS, BUT THERE IS GREATER THAN NORMAL RESISTANCE WHEN ATTEMPTING PUSH. CUSTOMER ALSO STATED HE HAS HAD A LOT OF BENT CANNULAS SO HE IS INSERTING ON HIS LEGS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498506 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG00XG9

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR