Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "216, 161, 336 AND 367 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN AN UNKNOWN TIME OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE NOT REPORTED; 30 UNITS EVERY NIGHT ON A SELF-ADJUSTING DOSE). THE PATIENT CLAIMED THAT AT AN UNSPECIFIED TIME ON (B)(6) 2020, SHE TOOK A SHOT OF INSULIN (AMOUNT NOT REPORTED) IN RESPONSE TO AN ALLEGED INACCURATE RESULT OF "247 MG/DL" WITH THE SUBJECT METER. THE PATIENT CLAIMED THAT 2 HOURS LATER SHE DEVELOPED SYMPTOM OF FEELING "SWEATY" AND HER BLOOD GLUCOSE TESTED "54 MG/DL" ON THE SUBJECT METER. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA 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 SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING ALLEGED INACCURATE RESULTS WITH THE SUBJECT METER. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.