BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 2884468 · Received December 22, 2012

    Report

    Report Number
    3004209178-2012-91533
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    INSPECTED THREE RANDOMLY SEALED RESERVOIRS. PERFORMED PRE-FILL RESERVOIR TEST. RESERVOIRS PASSED PER INSPECTION. NO TRANSFER GUARDS OCCLUDED ANOMALIES WERE FOUND DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. RAN BASAL AND BOLUS LEAKING TEST. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. NO LEAKAGE OR AIR BUBBLES. INSPECTED ONE OPENED AND USED RESERVOIR. PERFORM PRE-FILL RESERVOIR TEST. RESERVOIR PASSED PER SPECIFICATION. NO TRANSFER GUARD OCCLUDED ANOMALIES WERE FOUND DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. RAN BASAL AND BOLUS LEAKING TEST. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. NO LEAKAGE OR AIR BUBBLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER NOTICED AIR BUBBLES COMING PAST THE O-RINGS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8360136

    Patients

    Seq Age Sex Outcome Treatment
    1