BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1891401 · Received November 4, 2010

    Report

    Report Number
    2954323-2010-01523
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 14, 2010
    Report Date
    December 20, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER AND TEST STRIPS 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. ONE OF THE READINGS THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC METER. CUSTOMER REPORTED RECEIVING READINGS OF 416 MG/DL AND 102 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. THE CUSTOMER ALSO REPORTED FEELING WEAK, SQUEAMISH AND HIS LEGS FELT "LIGHT" AS A RESULT OF TAKING EXTRA METFORMIN WHEN HIS READING WAS HIGH. THE CUSTOMER REPORTEDLY SELF-TREATED BY DRINKING JUICE TO ALLEVIATE THE SYMPTOMS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV 50 DEVICE WAS OBSERVED LEAKING BEFORE USE. THE DEVICE WAS FILLED WITH 90MG OF PAMIDRONATE IN 250ML OF 0.9% SODIUM CHLORIDE AND THEN STORED IN THE REFRIGERATOR IN ITS ORIGINAL OVERPOUCH. SOLUTION WAS THEN OBSERVED COLLECTING INSIDE THE OVERPOUCH. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1025013

    Patients

    Seq Age Sex Outcome Treatment
    1