Description of Event or Problem · 1
ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READING OF ¿153, 224, 88 MG/DL¿ WITH THE SUBJECT METER AND ¿265, 110 MG/DL¿ WITH ANOTHER DEVICE (ULTRA 2), PERFORMED WITHIN 30 MINUTES FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. AFTER FURTHER REVIEW OF THE INFORMATION PROVIDED, THE REPORTER WAS ALLEGING THAT THE SUBJECT METER READING INACCURATELY ERRATIC. THE BLOOD GLUCOSE READINGS OF ¿153, 224, 88 MG/DL¿ WITH THE SUBJECT METER WERE PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.