BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2874890 · Received December 16, 2012

    Report

    Report Number
    3008382007-2012-08288
    Event Type
    Injury
    Date Received
    December 16, 2012
    Report Date
    November 26, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2012. THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE OCCURRED. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED POWER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF BLURRY VISION SEVERAL DAYS LATER (DATE/TIME NOT SPECIFIED). THE PATIENT, HOWEVER, DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED POWER ISSUE OCCURRED. DURING TROUBLESHOOTING, THE CSR VERIFIED THERE WAS NO MISUSE OF THE LFS PRODUCT, THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, AND THE PATIENT WAS USING THE CORRECT TEST STRIPS AT THE TIME THE ALLEGED ISSUE OCCURRED. THE CSR ALSO NOTED THAT THE SUBJECT METER TURNED ON MANUALLY WITH THE POWER BUTTON AND WITH THE TEST STRIP. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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 ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening