BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2230061 · Received August 31, 2011

    Report

    Report Number
    2939301-2011-08442
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (10/19/2011)-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 TESTING WITH NO FAULTS FOUND. 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

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL 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. 510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN THE (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION INITIALLY PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 11:30 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 5.8 MMOL/L ON THE REPORTED METER, AND A READING OF 3.8 MMOL/L ON A BACKUP METER. FOLLOWING THESE READINGS, THE PATIENT ATE A MEAL AND TOOK HIS "USUAL" DOSE OF INSULIN. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT PASSED OUT. THE PATIENT'S SON REVIVED HIM AND TREATED HIM WITH SIX GLUCOSE TABLETS. EMERGENCY SERVICES WERE CONTACTED. PARAMEDICS ARRIVED ON (B)(6), 12:00 AM AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 3.1 MMOL/L. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE DOSE OF INSULIN TAKEN BASED ON THE 5.8 MMOL/L READING, THE PATIENT'S EXPECTED READINGS AT THAT TIME OF NIGHT, THE TIME OF THE ONSET OF SYMPTOMS, HOW THE PATIENT WAS REVIVED, HIS DIABETES MEDICATION REGIMEN, AND WHAT TREATMENT, IF ANY, HE RECEIVED FROM THE PARAMEDICS. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT, AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. QUALITY CONTROL TESTING WAS PERFORMED DURING THE TROUBLESHOOTING TELEPHONE CALL, WITH PASSING RESULTS. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068728

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R