BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2218532 · Received August 22, 2011

    Report

    Report Number
    2939301-2011-07728
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    September 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K093745. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DIRTY SPC PIN. IN ADDITION, THE SPC PIN 1 WAS FOUND HIGH. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    THE LAY USER/ PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN APPLY SAMPLE MESSAGE ON THEIR ONE TOUCH ULTRAEASY METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE ALLEGED ISSUE WITH THE APPLY SAMPLE BEGAN ON (B)(6) 2011. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE. THE PATIENT DOES NOT TAKE ANY DIABETES MEDICATION. SHE BASICALLY DOES NOT INTAKE NO SUGAR, NO CARBOHYDRATES AND CONSUMES A WIDE VARIETY OF FRUITS AND VEGETABLES. SHE DID NOT CHANGE HER DIET. THE FOLLOWING DAY AT AN UNSPECIFIED TIME, SHE HAD DEVELOPED SYMPTOMS OF DRY MOUTH, DIFFICULTY SPEAKING, EXPERIENCED DROWSINESS AND LOSS OF CONSCIOUSNESS. WHEN HER HUSBAND ARRIVED, HE FOUND HER ALMOST UNCONSCIOUS AND INJECTED HER WITH GLUCAGON INJECTION. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION AND WAS NOT TAKEN TO THE HOSPITAL. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE APPLY SAMPLE MESSAGE, SHE WAS UNABLE TO TEST AND THE FOLLOWING DAY DEVELOPED SYMPTOMS AND HAD TO BE TREATED BY HER HUSBAND WITH A GLUCAGON INJECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention