BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2485488 · Received March 9, 2012

    Report

    Report Number
    2939301-2012-02376
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 16, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012 AT 12PM. THE PATIENT REPORTEDLY OBTAINED (ON AN UNSPECIFIED DATE/TIME) BLOOD GLUCOSE RESULTS OF "152, 137, 98, 150, 146, 148, AND 94MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HER DIABETES WITH 25 UNITS OF NOVOLIN TWICE A DAY. IT IS UNCLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. ON THE MORNING OF (B)(6) 2012 (TIME NOT KNOWN), THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SHAKING, SWEATING, NAUSEA, AND CONFUSION. HOWEVER, IT IS UNCLEAR WHAT THE PATIENT'S PREVIOUS BLOOD GLUCOSE RESULT WAS (WITH THE SUBJECT METER) PRIOR TO THE ONSET OF HER SYMPTOMS AND WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE PREVIOUS READING. IT IS UNCLEAR IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER WHEN HER REPORTED SYMPTOMS BEGAN AND IT IS ALSO NOT KNOWN IF THE PATIENT RECEIVED TREATMENT IN RESPONSE TO HER SYMPTOMS. FOR REASONS UNCLEAR, ON (B)(6) 2012 (AT 1AM) THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS PRIOR TO CONTACTING THE EMS. THE PATIENT REPORTEDLY WAS TESTED WITH THE EMS'S METER (READING UNKNOWN) AND WAS ADMINISTERED FOOD AND/OR DRINK AS TREATMENT BY THE HEALTH CARE PROFESSIONAL (HCP).IT IS NOT KNOWN IF THE PATIENT TESTED WITH THE SUBJECT METER AFTER RECEIVING TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE PATIENT'S USE OF THE SUBJECT METER, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND WAS ALLEGEDLY TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3214345

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R