Description of Event or Problem · 0
ON (B)(6) 2021, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT DID NOT REPORT WHEN THE SUBJECT METER STARTED READING ALLEGEDLY ERRATIC. THE PATIENT INFORMED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF ¿410, 143, 153, 163 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED THAT HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMS THAT HE DOES NOT KNOW HOW MUCH INSULIN TO TAKE BECAUSE OF THE HIGH DIFFERENCE BETWEEN THE READINGS. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED THE SYMPTOM OF ¿CLOUDY VISION¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT FOR THE REPORTED SYMPTOM. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA ESTABLISHED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THERE IS EVIDENCE OF DELAY IN TREATMENT AS THE PATIENT CLAIMS THAT HE DID NOT KNOW HOW MUCH INSULIN TO TAKE BASED ON THE READINGS FROM THE SUBJECT METER.