Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ONE YEAR PRIOR TO CONTACTING LFS; EXACT DATE AND TIME NOT REPORTED. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "163, 133, 196, 252 AND 102 MG/DL" WITH THE SUBJECT METER AND RESULTS OF "131, 112, 161, 186 AND 64" ON THE CGM DEVICE, PERFORMED WITHIN AN UNKNOWN TIME OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH LANTUS AND HUMALOG INSULIN. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTED TAKING MORE INSULIN THAN USUAL (TYPE AND DOSE NOT REPORTED). THE PATIENT CLAIMED THAT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE BEGAN, HE DEVELOPED SYMPTOM OF "SWEATING," BUT DENIED RECEIVING ANY TREATMENT ABOVE AND BEYOND HIS USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER TAKING EXTRA INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.