BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT LANCETS

    MDR report key: 1955305 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00303
    Event Type
    Injury
    Date Received
    January 10, 2011
    Report Date
    December 15, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) VIA E-MAIL ALLEGING THAT HIS LANCET (TYPE UNSPECIFIED) CAUSED AN INFECTION AT THE PUNCTURE SITE ON HIS FINGER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE DATE WHEN THE PATIENT NOTICED THE INFECTION (ON HIS FINGER) IS NOT KNOWN, IT IS NOT SPECIFIED IF THE PATIENT IS USING THE ONETOUCH LANCETS OR IF THE PATIENT OWNS ADDITIONAL NON-LFS BRAND LANCETS, AND IT IS NOT KNOWN IF THE PATIENT PURCHASED THE UNSPECIFIED LANCETS FROM A REPUTABLE SOURCE. IT IS NOT KNOWN IF THE PATIENT WAS USING THE UNSPECIFIED LANCET FOR THE FIRST TIME. IT IS NOT SPECIFIED IF THE PATIENT CHANGES HIS LANCET AFTER EACH USE. IT IS NOT KNOWN HOW THE PATIENT CLEANS HIS HANDS PRIOR TO TESTING HIS BLOOD GLUCOSE. IT IS NOT KNOWN IF THE ALLEGED ISSUE OCCURRED AT ANY OTHER TESTING SIGHTS. IT IS NOT SPECIFIED HOW SOON AFTER THE INFECTION DEVELOPED AFTER USING THE UNSPECIFIED LANCET. IT IS NOT KNOWN WHAT TYPE OF TREATMENT, IF ANY, THE PATIENT ADMINISTERED AFTER DISCOVERING THE INFECTION. DURING A DOCTOR'S OFFICE VISIT (ON (B)(6)), THE PATIENT CLAIMED HIS PHYSICIAN "OPENED UP" HIS MIDDLE FINGER TO "EASE THE PAIN". IT IS NOT SPECIFIED IF THE PATIENT'S PHYSICIAN PROVIDED ADDITIONAL MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN. ALTHOUGH IT IS NOT KNOWN IF THE PATIENT IS USING THE ONETOUCH LANCETS, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT LANCETS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R