BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2419936 · Received January 18, 2012

    Report

    Report Number
    2939301-2012-00663
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: NOT PROVIDED. THE 510(K) # IS K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI KIT WAS MISSING TEST STRIPS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DISCOVERED THE ALLEGED ISSUE ON (B)(6) 2011. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND OTHER THAN DIABETES, IT IS CLEAR IF THE PATIENT HAS ANY OTHER HEALTH CONDITIONS. THE PATIENT INDICATED SHE DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN. AFTER DISCOVERING THE ALLEGED ISSUE, IT IS UNCLEAR WHAT ACTION , IF ANY, THE PATIENT TOOK IN RESPONSE TO HER DIABETES MANAGEMENT AND IT IS NOT KNOWN IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH ANOTHER/ SECONDARY DEVICE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT ON (B)(6) 2011 (TIME NOT SPECIFIED) SHE DEVELOPED SYMPTOMS OF "NAUSEA, FAINTING, WATERY MOUTH" AND ADMINISTERED TREATMENT BY CONSUMING MORE FOOD/DRINK THAT MORNING. DURING TROUBLESHOOTING, THE CSR EDUCATED THE PATIENT ON THE CORRECT BOX CONTENTS OF THE KIT AND NOTED THAT THERE WAS NO MISSING PRODUCT FROM THE KIT. TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER DISCOVERING THE ALLEGED ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R