BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2523163 · Received April 9, 2012

    Report

    Report Number
    2939301-2012-03529
    Event Type
    Injury
    Date Received
    April 9, 2012
    Report Date
    April 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRAMINI METER WAS EXPERIENCING A CALCODE ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE AND TIME. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. AT AN UNSPECIFIED DATE AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "SWEATY AND LIGHTHEADED" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052119

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening