BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1813459 · Received August 24, 2010

    Report

    Report Number
    2954323-2010-01163
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND EXTENDED INVESTIGATIONS HAVE BEEN COMPLETED. THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE METER POWER ISSUE WAS DUE TO A HARDWARE COMPONENT FAILURE. ALTHOUGH GLUCOSE RESULTS MAY BE DELAYED, BLOOD GLUCOSE COULD BE DETERMINED BY ALTERNATE MEANS, INCLUDING USE OF ANOTHER BLOOD GLUCOSE METER, SEEING A PHYSICIAN (AS RECOMMENDED IN PRODUCT LABELING), OR BY SEEKING TREATMENT AT A HEALTH CARE FACILITY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION WILL BE UNDERTAKEN UPON RECEIPT OF THE CUSTOMER'S PRODUCTS. A FINAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER SN# (B)(4) WAS RETURNED AND INVESTIGATED. THE METER DID NOT POWER ON WITH STRIP INSERTION OR WITH BUTTON DEPRESSION. THE METER WAS DISASSEMBLED AND NO CORROSION WAS FOUND ON THE METER'S PRINTED CIRCUIT BOARD. CONTINUITY TESTS ON THE PRINTED CIRCUIT BOARD WERE PERFORMED. THE METER IS STILL UNDER INVESTIGATION AND AN ADDITIONAL REPORT WILL BE SENT ONCE NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 5 OF 6. THE NURSE STATED THE DETAILS OF THE ERROR WERE UNKNOWN. THE NURSE THOUGHT THE PATIENT DISCONNECTED, CAUSING THE ALARM. GTS SUGGESTED THAT THE NURSE LET THE PATIENT'S DIALYSIS NURSE KNOW ABOUT THE ERROR. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE PATIENT?S DIALYSIS NURSE. THE NURSE STATED THAT SHE WAS CONTACTED AND INFORMED THAT THE PATIENT WAS DISCONNECTED DURING THERAPY. THE NURSE DID NOT KNOW IF THE DISCONNECTION WAS INTENTIONAL OR UNINTENTIONAL OR WHERE IT OCCURRED DURING SETUP. IT IS UNKNOWN IF THE PATIENT WAS RECONNECTED TO THE SET UP AFTER THIS DISCONNECTION. THE NURSE STATED SHE WAS CONTACTED AGAIN AFTER THE INITIAL CALL AND WAS INFORMED THAT THE HOME CHOICE (HC) WAS ALARMING SYSTEM ERROR 2240. NO ADDITIONAL INFORMATION WAS AVAILABLE ON SAMPLE AVAILABILITY OR IF ANYTHING UNUSUAL WAS NOTED WITH THE SUPPLIES USED.

    Description of Event or Problem · 1

    CUSTOMER'S BOYFRIEND REPORTED THAT ON (B)(6) 2010 CUSTOMER NOTICED A BLANK SCREEN (THE METER WOULD NOT TURN ON WITH THE BUTTON OR WITH TEST STRIP INSERTION) ON THE DISPLAY OF HER FREESTYLE LITE BLOOD GLUCOSE METER. HE FURTHER REPORTED THE NEXT DAY CUSTOMER EXPERIENCED CONFUSION, MEMORY LOSS AND A SEIZURE. NO THIRD-PARTY EMERGENT INTERVENTION WAS REPORTED. CUSTOMER DENIED SELF-TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0919813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other