BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3120579 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12144
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING ON (B)(4) 2013, WITH NO FAULTS FOUND AND THE COMPLAINT WAS NOT CONFIRMED. THE TEST STRIPS WERE ALSO TESTED ON (B)(4) 2013 AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. DATE OF EVENT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE IN (B)(6) 2013, AT 6:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 345 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH COMPARED TO HIS EXPECTED VALUES. THE PATIENT TOOK NO ACTIONS DUE TO THIS READING. AT THAT TIME, THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. EMERGENCY SERVICES WERE CONTACTED AND PARAMEDICS OBTAINED A READING OF 47 MG/DL FOR THE PATIENT¿S BLOOD GLUCOSE LEVEL. THE PATIENT WAS TREATED WITH GLUCOSE TABLETS OR GEL. THE PATIENT MANAGED HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT RETURNED HIS METER AND TEST STRIPS TO LFS FOR EVALUATION, AND BOTH PRODUCTS PASSED TESTING WITH NO PROBLEMS FOUND. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222796 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3378887

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R