BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2192023 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06835
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/13/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. 510K#: K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE (B)(6) MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 3:30 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 80 MG/DL ON THE REPORTED METER. AT 3:45 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING AND ANXIETY. THE PATIENT'S WIFE TREATED HIM WITH JUICE AND GLUCOSE, AND CONTACTED EMERGENCY SERVICES. PARAMEDICS ARRIVED, AND AT 5:45 PM TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL USING THEIR METER TO BE 32 MG/DL. THE PATIENT TESTED USING THE REPORTED METER, AND OBTAINED A READING OF 82 MG/DL. THE PATIENT RECEIVED FURTHER FOOD AND DRINK AS TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE OBTAINED A NORMAL BLOOD GLUCOSE READING OF 80 MG/DL ON THE REPORTED METER, AND RECEIVED EMERGENCE MEDICAL ATTENTION AND TREATMENT. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3148948

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R