A pt using freestyle lite test strips (lot #1366118) in an omnipod meter/control unit had repeated erroneously low glucose readings.
Because she had faulty info she did not recognize the onset of hyperglycemia and then diabetic ketoacidosis.
She subsequently died.
The suspect test strips and meter were in my possession on (b)(6) 2013.
I tested the suspect strips/meter with normal freestyle control solution and received a reading of 23 mg/dl.
I immediately repeated the test on the same meter with freestyle lite strips of a different lot (#1361309) with a correct reading of 90 mg/dl.
I and an employee both did "in vivo" testing using first our personal meters and then the suspect equipment.
My employee had a glucose of 180 (on two other devices) with a reading of 36 on the suspect equipment.
I had a reading of 109 on my meter and 26 on the suspect equipment.
This clearly indicated that the strips/meter in the pt's possession at the time of death were reporting erroneously low glucose levels.