BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1869963 · Received October 14, 2010

    Report

    Report Number
    2954323-2010-01432
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 17, 2010
    Report Date
    December 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 1013339. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READINGS REPORTED WERE NOT FOUND IN THE INTERNAL MEMORY LOG OF THE METER. CORRECTION: REQUESTED PRODUCT WAS RECEIVED AND INVESTIGATED PRIOR TO FOLLOW UP #1 SUBMISSION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(6) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT A COLLEAGUE INFUSION PUMP HAD FAILURE CODE 550:320 WITH A PINCHED SPEAKER WIRE DURING RECERTIFICATION. THE DEVICE MAY NOT HAVE AUDIBLY ALARMED. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER'S SON REPORTED THAT ON (B)(6) 2010 AT 1215 HIS MOTHER RECEIVED A FS LITE METER READING OF 85MG/DL AND REPORTED AT THE TIME HIS MOTHER WAS "NON-RESPONSIVE". CUSTOMER DENIED HIS MOTHER HAD LOST CONSCIOUSNESS BUT SHE REMAINED "NON-RESPONSIVE" SO PARAMEDICS WERE CALLED. UPON ARRIVAL, THE PARAMEDICS OBTAINED AN HCP METER READING OF 35MG/DL. IT WAS REPORTED PARAMEDICS TREATED HER WITH "SOME TYPE OF GLUCOSE" (SPECIFIC TYPE AND ROUTE OF ADMINISTRATION WAS NOT REPORTED). CUSTOMER WAS THEN TRANSPORTED TO A HEALTH CARE FACILITY, DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN ADDITIONAL GLUCOSE (ROUTE UNKNOWN) AND HER "MEDICATION WAS ADJUSTED" (TYPE OF MEDICATION UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1013339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R