BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2032497 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02675
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K053529. 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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR A FOLLOW-UP. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN APPROXIMATELY 1 WEEK PRIOR TO CONTACTING LFS. THE CSR NOTED THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. ON AN UNSPECIFIED DATE, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED HE DEVELOPED "HIGH SUGAR SYMPTOMS AND DOUBLE VISION". THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT HAD NOT REPLACED THE SUBJECT METER'S BATTERY PER THE RECOMMENDATIONS IN THE OWNER'S BOOKLET. THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE AT THE TIME OF THE CALL. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED "HIGH SUGAR SYMPTOMS" AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3057772

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening