BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 2017951 · Received March 14, 2011

    Report

    Report Number
    2939301-2011-02165
    Event Type
    Injury
    Date Received
    March 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS/HER ONETOUCH BASIC ORIGINAL METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN 2 MONTHS AGO PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED HE/SHE MANAGES HIS/HER DIABETES WITH ORAL MEDICATIONS AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED HE/SHE CONTINUED TO TAKE 10 MG OF GLUCOTROL AND 500-1000MG OF METFORMIN AS USUAL. THE PATIENT INDICATED HE/SHE DEVELOPED SYMPTOMS OF DIZZINESS AND BLURRY VISION 2 DAYS AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT STATED HE/SHE WENT TO SEE HIS/HER HEALTH CARE PROVIDER (HCP) A WEEK PRIOR TO CONTACTING LFS. ACCORDING TO THE PATIENT, HE/SHE WAS PRESCRIBED 30MG OF ACTOS TO TAKE TWICE DAILY AND WAS INFORMED TO CONTINUE TAKING METFORMIN TWICE DAILY. AT THE TIME OF THE DOCTOR'S OFFICE VISIT, THE PATIENT INDICATED HE/SHE WAS TESTED BY THE DOCTOR'S/CLINIC METER; HOWEVER THE PATIENT WAS NOT ABLE TO RECALL THE RESULT OR THE TIME WHEN IT WAS TAKEN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER TO THE SUBJECT METER AND THAT THERE WAS NO MISUSED OF THE METER. BASED ON THE INFORMATION PROVIDED, THE METER NEEDED A NEW BATTERY; HOWEVER THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE AT THE TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE/SHE WAS UNABLE TO TEST HIS/HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2861341

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening