Description of Event or Problem · 1
ON (B)(6) 2020, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ULTRA METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON AN UNSPECIFIED DATE, DURING THE WEEK SHE CONTACTED LFS. THE PATIENT CLAIMED THAT THROUGHOUT THE COURSE OF THE WEEK SHE CONTACTED LFS, SHE OBTAINED BLOOD GLUCOSE RESULTS OF ¿78, 64, 160, 171, 200, 172, 187 AND 231 MG/DL¿ WITH THE SUBJECT DEVICE. THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTED INSULIN (30 UNITS OF LANTUS AND HUMALOG) AND SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AT 1 P.M., ON (B)(6) 2020, SHE TESTE HER BLOOD GLUCOSE USING THE SUBJECT DEVICE AND CLAIMED OBTAINING A RESULT OF ¿231 MG/DL¿; HOWEVER, ADVISED THAT SHE BELIEVED THIS TO BE INACCURATE AS SHE WAS FEELING ¿SHAKY¿ WHICH SHE ASSOCIATED WITH A LOW BLOOD GLUCOSE EXCURSION. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGED INACCURACY ISSUE. 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 ISSUE OCCURRED.