Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (ONETOUCH ULTRA 2). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2017 AT 8:51 AM. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF BETWEEN ¿311 MG/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 ALSO REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿254, 258 AND 254 MG/DL¿ WITH THE SUBJECT METER AND ¿72, 74 AND 79 MG/DL¿ RESPECTIVELY ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. IT WAS NOT REPORTED IF THE PATIENT TAKES ANY MEDICATION TO MANAGE HER DIABETES OR IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED ISSUE. THE PATIENT STATED THAT 30 MINUTES TO 1 HOUR PRIOR TO THE START OF THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS OF FEELING ¿LIGHTHEADED, IRRITABLE AND FLOATERS IN EYE.¿ THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR DOCUMENTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CSR NOTED THE PATIENT WAS TESTING WITH TEST STRIPS THAT APPEARED IN GOOD CONDITION, WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CSR WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL OUTSIDE THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILE USING THE PRODUCT. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.