BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1760052 · Received July 16, 2010

    Report

    Report Number
    2954323-2010-00950
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 19, 2010
    Report Date
    September 20, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS CUSTOMER'S PRODUCT HAS NOT YET BEEN RETURNED, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. IT SHOULD BE NOTED: THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS GREATER THAN 500 MG/DL. A "HI" DISPLAY MESSAGE INDICATES A READING GREATER THAN 500 MG/DL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHUNT TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT BRACHIAL ARTERY. A 5.0 X 40/40 STERLING BALLOON DILATATION CATHETER WAS SELECTED AND INFLATED TO 6ATMS. ON THE SECOND INFLATION AT 12 ATMS A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED CUSTOMER RECEIVED A RESULT OF 251 MG/DL ON HER FREESTYLE LITE BLOOD GLUCOSE METER ON (B) (6) 2010, THAT WAS HIGHER THAN SHE FELT, AFTER FEELING HYPOGLYCEMIC AND SELF-TREATING WITH SODA. IT WAS FURTHER REPORTED THAT ON (B) (6) 2010 CUSTOMER EXPERIENCED DIAPHORESIS, DETERIORATING SPEECH AND A LOSS OF CONSCIOUSNESS AFTER SELF-ADMINISTERING (VIA INSULIN PUMP) 10 UNITS REGULAR INSULIN IN RESPONSE TO A RESULT OF "HI" RECEIVED ON HER METER, WHICH WAS RECEIVED AFTER SELF-TREATING WITH GLUCOSE GEL. IT IS UNKNOWN IF THERE WERE ANY READINGS OBTAINED PRIOR TO THE CUSTOMER'S ATTEMPTS AT SELF-TREATMENT. ATTEMPTS TO RE-CONTACT THE CUSTOMER TO CLARIFY THE SEQUENCE OF EVENTS LEADING UP TO THE REPORTED LOSS OF CONSCIOUSNESS HAVE BEEN UNSUCCESSFUL TO DATE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0936430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R