BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2183193 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06578
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING HER SON'S ONETOUCH ULTRAMINI METER WAS PROMPTING FOR A BLOOD SAMPLE AFTER THE SAMPLE WAS ALREADY APPLIED TO THE STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AN UNKNOWN TIME. THE PATIENT WAS UNABLE TO GET A BLOOD GLUCOSE READING DUE TO AN "APPLY SAMPLE" PROMPT ON THE DISPLAY AFTER THE SAMPLE HAD ALREADY BEEN APPLIED. THE PATIENT'S MOTHER STATED THAT THE PATIENT WAS NOT TAKING ANY MEDICATIONS FOR DIABETES AND APPROXIMATELY 20 MINUTES AFTER NOT BEING ABLE TO CHECK HER SON'S BLOOD GLUCOSE, HE DEVELOPED A SYMPTOM OF "SHAKING." THE MOTHER STATED HE WAS TREATED WITH FOOD AND DRINK AND DENIED TESTING ON ANOTHER DEVICE. IT IS UNKNOWN IF THE SYMPTOMS ABATED AFTER THE TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THIS WAS THE FIRST TIME THE SUBJECT METER WAS BEING USED AND THE PATIENT'S MOTHER WAS APPLYING THE BLOOD TO AN INCORRECT PART OF THE STRIP. THE ISSUE WAS RESOLVED BY WALKING HER THROUGH A SUCCESSFUL BLOOD TEST OVER THE PHONE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S MOTHER CLAIMS SHE WAS UNABLE TO TEST THE PATIENT'S BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND HE REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3074796

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening| R