BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC-FREE ADMIN.SET

    MDR report key: 1873268 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04232
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLE IS AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND THE REPORTED CONDITION WAS CONFIRMED. THE INSPECTION OF THE DEFECTIVE UNIT UNDER AN OPTICAL MICROSCOPE REVEALED THAT ONLY THE TOP OF THE MILLIPORE FILTER WAS CRACKED (THE LUER LOCK WAS NOT DAMAGED). THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND DID NOT FIND ANY SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW. PATIENT REPORTED HIS CGM WAS READING AROUND 136 MG/DL WHEN HE BECAME DAZED AND CONFUSED. HIS FRIENDS TRIED TREATING HIM AND GIVING HIM JUICE. PARAMEDICS WERE CALLED, AND PATIENT'S FINGERSTICK VALUE WAS 36 MG/DL WHEN THEY ARRIVED. PARAMEDICS ADMINISTERED IV, AND PATIENT RECOVERED. PATIENT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6), 2010 AN INCIDENT WHERE A CRACK WAS NOTICED ON THE ADMINISTRATION SET, CAUSING A LEAK. THIS PATIENT WAS SET TO RECEIVE REMICADE AND THE FLOOR WAS WET FOLLOWING THIS LEAK. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVC-FREE ADMIN.SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10E03V396M

    Patients

    Seq Age Sex Outcome Treatment
    1