Description of Event or Problem · 1
ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT TWO ONETOUCH ULTRA2 METERS DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FOLLOWING A REVIEW OF THE CALL BY MEDICAL SURVEILLANCE. THE PATIENT WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT STARTING AROUND NOON ON (B)(6) 2019, SHE BEGAN GETTING BLOOD GLUCOSE RESULTS HIGHER THAN HER NORMAL RESULTS OF AROUND ¿106 AND 93 MG/DL¿; SHE REPORTED RESULTS OF ¿133, 257, 187, 260 UP TO 420 MG/DL¿ WHICH SHE CONSIDERED WERE TOO HIGH. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT WOULD NOT SPECIFY WHAT MEDICATIONS SHE TAKES TO MANAGE HER DIABETES. SHE REPORTED THAT SHE DID NOT BELIEVE THE RESULTS SHE OBTAINED, AND, AS A RESULT, DID NOT KNOW WHAT MEDICATIONS TO TAKE. SHE RESTATED THAT AROUND 2 HOURS AFTER OBTAINING ALLEGED INACCURATE RESULTS, SHE DEVELOPED SYMPTOMS OF ¿DIZZINESS, LIGHT HEADED, HEAVY SWEATING AND ALMOST FAINTING¿, WHICH SHE ASSOCIATED WITH HYPOGLYCEMIA. SHE STATED THAT SHE TREATED THE SYMPTOMS BY DRINKING ¿EXCESSIVE AMOUNTS OF LIQUID THAT WAS SWEETENED AND GLUCOSE TABLETS¿. SHE STATED THAT SHE CONTINUED TO OBTAIN, WHAT SHE CONSIDERED TO BE INACCURATELY HIGH BLOOD GLUCOSE RESULTS, OVER THE FOLLOWING DAYS, SO PURCHASED A NEW ONETOUCH ULTRA 2 METER AND TEST STRIPS ON (B)(6) 2019. SHE STATED THAT SHE CONTINUED TO EXPERIENCE THE SAME ISSUES WITH THE NEW METER AND TEST STRIPS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THAT THE METER HAD BEEN SET TO THE CORRECT UNIT OF MEASURE. SHE ALSO CONFIRMED THAT HER TEST STRIPS WERE WITHIN EXPIRY DATE AND HAD BEEN STORED CORRECTLY. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE METER AND TEST STRIPS. EDUCATION WAS PROVIDED BY THE CCA AND REPLACEMENT PRODUCTS, INCLUDING CONTROL SOLUTION, WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, I.E. DIZZINESS, LIGHT HEADED, HEAVY SWEATING AND ALMOST FAINTING WHICH SHE ASSOCIATED WITH HYPOGLYCEMIA, AFTER OBTAINING ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS ON THE SUBJECT METER AND NOT TAKING MEDICATION.