BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1826964 · Received September 7, 2010

    Report

    Report Number
    2954323-2010-01238
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 10, 2010
    Report Date
    October 5, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER AND REPORTED TEST STRIP LOT #1013144 WERE RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. FOUR OF THE FIVE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY HOWEVER, THEY WERE OBTAINED ON THREE SEPARATE DAYS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 96 MG/DL, 110 MG/DL, 97 MG/DL, 505 MG/DL, AND 299 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A US NURSE OF INFECTION IN A FINGER AND FATAL FUNGAL PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE REPORTED ON AN UNSPECIFIED DATE IN 2010, THE PATIENT DEVELOPED AN INFECTION IN A FINGER (UNKNOWN) WHICH REQUIRED AMPUTATION. ON AN UNSPECIFIED DATE IN 2010, THE PATIENT EXPERIENCED FUNGAL PERITONITIS. IT IS UNKNOWN WHAT TREATMENT AND INTERVENTIONS WERE PROVIDED FOR THE FUNGAL PERITONITIS. ON (B)(6)2010, THE PATIENT EXPIRED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS REPORTED AS FUNGAL PERITONITIS. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. PER THE NURSE, THE EVENTS OF INFECTION IN THE FINGER AND FATAL FUNGAL PERITONITIS WERE UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1013144

    Patients

    Seq Age Sex Outcome Treatment
    1