BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1860625 · Received October 7, 2010

    Report

    Report Number
    2954323-2010-01401
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 31, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010 AT 12:45 PM SHE RECEIVED A READING OF 110 MG/DL ON HER FREESTYLE LITE BLOOD GLUCOSE METER, AND AT 2:30 PM OF THE SAME DAY, SHE EXPERIENCED DIAPHORESIS AND LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND REPORTEDLY TREATED THE CUSTOMER WITH AN INJECTION OF A "GLUCOSE PEN". THE CUSTOMER ALSO REPORTED THAT A READING OF 87 MG/DL WAS OBTAINED ON A HEALTH CARE PROVIDER DEVICE, BUT IT IS UNKNOWN IF THE READING OF 87 MG/DL WAS OBTAINED BEFORE OR AFTER THE ADMINISTRATION OF GLUCOSE. THE CUSTOMER ADDITIONALLY REPORTED SHE DRANK ORANGE JUICE. SHE WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(6) ON (B)(6) 2010 FROM (B)(6) HOSPITAL VIA THE ACCOUNT MANAGER. IT WAS REPORTED THAT ON (B)(6) 2010 AN AQUARIUS MACHINE WAS INVOLVED IN AN EXCESSIVE FLUID REMOVAL INCIDENT. THE CUSTOMER BELIEVES THAT THE INCIDENT WAS LARGELY DUE TO USER TRAINING ISSUES. NO PATIENT INJURY/HARM REPORTED. THE MACHINE WAS NOT AVAILABLE FOR EVALUATION AND THE ACCOUNT MANAGER BELIEVES THE MACHINE IS BACK IN USE AFTER SERVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1012038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R