LifeScan · Model OneTouch Select
• OneTouch Select Blood Glucose Meter (battery included) • OneTouch Lancing Device and Lancets • OneTouch Owner’s Booklet and Starter Guide • Logbook • Carrying case • The OneTouch Select Meter uses OneTouch Select Test Strips and OneTouch® • Select Control Solutions, which are sold separately.
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The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display.
Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.
Products may provide inaccurate results at readings over 400 mg/dL
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
Product may be defective and may give low inaccurate glucose results.
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.
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