BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2521836 · Received April 6, 2012

    Report

    Report Number
    2939301-2012-03472
    Event Type
    Injury
    Date Received
    April 6, 2012
    Report Date
    March 20, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH SELECT METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY REPORTER THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE AND TIME IN THE BEGINNING OF (B)(6) 2012. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATIONS, 500MG OF METFORMIN AND 5MG OF ONGLYZA, AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "BLURRY VISION" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. THE CCA NOTED THAT THE BATTERIES DID NOT NEED REPLACEMENT. 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 SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3229276

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening