BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC ENHANCED METER

    MDR report key: 2367694 · Received December 12, 2011

    Report

    Report Number
    2939301-2011-12170
    Event Type
    Injury
    Date Received
    December 12, 2011
    Report Date
    November 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE 510(K) # IS K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT FROM (B)(6) CONTACTED LIFESCAN (LFS) UNITED STATES ALLEGING THAT HIS ONETOUCH BASIC METER WAS READING INACCURATELY HIGH COMPARED TO A LABORATORY RESULT. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN A YEAR PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY TESTED WITH THE SUBJECT METER AND A LABORATORY DEVICE WITHIN 10-30 MINUTES OF EACH OTHER; THE PATIENT'S BLOOD GLUCOSE RESULTS, HOWEVER, ARE NOT KNOWN. THE PATIENT'S TESTING FREQUENCY AND DIABETES MANAGEMENT ARE NOT KNOWN AND IT IS ALSO NOT SPECIFIED WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF "SWEATING" AND "HEART BEATING" (DATE/TIME NOT KNOWN). IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION/TREATMENT AFTER THE REPORTED METER ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT DID NOT HAVE ALL OF HIS TESTING SUPPLIES AVAILABLE. THE ALLEGED ISSUE REMAINS UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening