BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2884179 · Received December 21, 2012

    Report

    Report Number
    3008382007-2012-08801
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. UNRELATED TO THE REPORTED ISSUE, THE NUMBER OF TEST STRIPS RETURNED WAS MORE THAN WHAT THE LABEL NUMBER SPECIFIED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/REPORTER, THE PATIENT'S DAUGHTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON THE MORNING OF (B)(6) 2012 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 172 MG/DL ON THE REPORTED METER. THE PATIENT TOOK NO ACTIONS BASED ON THIS READING. THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. AT A TIME GREATER THAN 20 MINUTES LATER, PARAMEDICS WERE CONTACTED AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 21 MG/DL. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION. THE PATIENT MANAGES HER DIABETES WITH SET DOSES OF INSULIN. THE PATIENT'S METER WAS RETURNED TO LIFESCAN FOR EVALUATION. THE METER WAS EVALUATED ON (B)(6) 2012 AND PASSED TESTING WITH NO ISSUES FOUND. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE OBTAINED AN ELEVATED READING ON THE REPORTED METER AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCAGON. 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 EUROPE, A DIVISION OF CILAG GMBH INTL 3366466

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R