BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 1893544 · Received November 8, 2010

    Report

    Report Number
    2939301-2010-09707
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    October 26, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K023948.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

    THE LAY USER / PATIENT CONTACTED LFS ON OCTOBER 26, 2010 ALLEGING A RETEST MESSAGE ON HER ONE TOUCH BASIC METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN SOMETIME IN (B)(6) 2010. THE PATIENT DID NOT TAKE ANY ACTION AFTER THE ALLEGED ISSUE BEGAN. APPROXIMATELY 2 MONTHS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY AND BLURRED VISION. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT DID NOT HAVE SUPPLIES AVAILABLE TO FURTHER TROUBLESHOOT WITH THE CUSTOMER CARE ADVOCATE (CCA). THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE "RETEST" MESSAGE, SHE WAS UNABLE TO TEST AND 2 MONTHS LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R