Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (PARAMEDIC¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN SEVERAL WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿197, 183, 210, 269, 279, 200, 334 AND 375 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN 2000 MG DAILY) AND INSULIN (HUMULIN R U-500; DOSE BASED ON BLOOD GLUCOSE READINGS). THE PATIENT REPORTED ADMINISTERING THE ¿WRONG DOSE¿ OF INSULIN AS A RESULT OF THE ALLEGED ISSUE; EXACT DOSE NOT REPORTED. THE PATIENT CLAIMED THAT WHILE ON THE PHONE TO HER DOCTOR ON (B)(6) 2020 AT AROUND 3:00 PM, SHE STARTED TO EXPERIENCE ¿BLURRY VISION, DOUBLE VISION AND BLACKED OUT.¿ THE PATIENT CLAIMED THAT WHEN THE PARAMEDICS ARRIVED, SHE OBTAINED BLOOD GLUCOSE READINGS OF ¿104 OR 106 MG/DL¿ WITH THE SUBJECT METER AND ¿58 MG/DL¿ ON THE PARAMEDIC¿S DEVICE, PERFORMED WITHIN SECONDS OF EACH OTHER. THE PATIENT WAS UNABLE TO RECALL THE TREATMENT PROVIDED BY THE PARAMEDICS BEFORE BEING RUSHED TO HOSPITAL. SHE WAS REPORTEDLY HOSPITALIZED FOR 3 DAYS. THE PATIENT WAS UNABLE TO RECALL THE EXACT TREATMENT RECEIVED IN HOSPITAL HOWEVER INDICATED SHE WAS GIVEN A DIFFERENT TYPE OF INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CSA NOTED THAT 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 SIGN/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT REQUIRING MEDICAL INTERVENTION AFTER TAKING INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.