Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY OCCURRED ON (B)(6). AT THIS TIME, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿250, 198 AND 150MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES THEIR DIABETES BY SELF-ADJUSTING THEIR INSULIN DOSAGE AND DID NOT MAKE ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT ONE AND A HALF HOURS AFTER THE ALLEGED PRODUCT ISSUE OCCURRED THEY DEVELOPED THE SYMPTOMS OF ¿SHAKING, EYES OUT OF FOCUS AND THIRSTY¿; HOWEVER, DID NOT REQUIRE ANY FORM OF TREATMENT AS A RESULT OF THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AND THE PATIENT DID NOT HAVE TEST STRIPS AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST ON THE SUBJECT METER. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING REPORTEDLY INACCURATE HIGH BLOOD GLUCOSE RESULTS WITH THE SUBJECT METER.