Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) MEXICO, ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (CONTOUR). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2020. THE PATIENT CLAIMED A NON-DIABETIC OBTAINED RESULTS OF ¿180 MG/DL¿ WITH THE SUBJECT METER AND ¿90 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT INFORMED THE CSA THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (TRAJENTA 1 PILL DAILY) AND 10 UNITS OF INSULIN IF NECESSARY, ON A SELF-ADJUSTING DOSE. THE PATIENT REPORTED THAT ON (B)(6) 2020 AT 5:00 PM, SHE TOOK 1 TRAJENTA PILL. THE PATIENT CLAIMED THAT AT 10:00 PM SHE TOOK AN INCREASED DOSE OF 20 UNITS OF INSULIN (INSULEX ISOPHANE) IN RESPONSE TO A RESULT OF ¿472 MG/DL¿ WHICH SHE OBTAINED WITH THE SUBJECT METER. AT 10:30 PM, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿COLD SWEAT, TONGUE TIED AND SHAKING.¿ THE EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY CONTACTED FOR ASSISTANCE AND SHE WAS TRANSPORTED TO HOSPITAL AT 11:00 PM WHERE SHE WAS GIVEN SWEETENED FOOD TO RAISE HER BLOOD GLUCOSE. THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS MEASURED ON THE EMS DEVICE BUT WAS UNABLE TO RECALL THE RESULT OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED 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 CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CSA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THAT THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CSA 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 SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT REQUIRING MEDICAL INTERVENTION AFTER THE ALLEGED METER INACCURACY BEGAN. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.