BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1560005 · Received December 15, 2009

    Report

    Report Number
    2954323-2009-02159
    Event Type
    Injury
    Date Received
    December 15, 2009
    Date of Event
    November 24, 2009
    Report Date
    January 8, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: AT 7:00PM, THE CUSTOMER RECEIVED A READING OF 55 MG/DL ON THEIR ADC METER WHICH IS CONSISTENT WITH THE CUSTOMER'S TREATMENT AND SYMPTOMS.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER AND STRIP LOT 0900205 WERE RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. AS THE CUSTOMER DID NOT REPORT SPECIFIC READINGS, THE READINGS IN THE METER FOR THE DAY OF THE EVENT WERE CONSISTENT WITH THE CUSTOMER'S COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. A TAXUS LIBERTE' 2.5X28MM STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) TO THE LEFT POSTEROLATERAL (LPL) BRANCH. APPROXIMATELY SIX MONTHS POST-PROCEDURE, THE PATIENT UNDERWENT FOLLOW-UP CORONARY ANGIOGRAPHY, AND IT WAS DISCOVERED THERE WAS IN-STENT RESTENOSIS OF THE TAXUS LIBERTE STENT. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS AT THIS TIME. THE RESTENOSIS WAS TREATED WITH AN APEX 2.0X15MM BALLOON AND A NON-BSC BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AT 5:00 PM, THEY RECEIVED UNKNOWN HIGH READINGS ON THEIR FREESTYLE LITE METER AND TOOK INSULIN ACCORDINGLY. AT 7:00 PM, THE CUSTOMER EXPERIENCED SEIZURES, A LOSS OF CONSCIOUSNESS AND CHEST PAIN. THE EMERGENCY RESPONDERS WERE CALLED AND TREATED THE CUSTOMER WITH A GLUCOSE DRIP AND MONITORED HIS HEART. THE CUSTOMER ALSO DRANK JUICE AND ATE FOOD TO HELP COUNTERACT THE MEDICAL EVENT. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0900205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R