Description of Event or Problem · 1
ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH 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 AT 10 A.M., ON (B)(6) 2018. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿243, 190 AND 117 MG/DL¿ WITH THE SUBJECT DEVICE, PERFORMED MORE THAN 20 MINUTES APART. THE TIME DIFFERENCE BETWEEN THE TESTS EXCEEDS LFS¿ CRITERIA FOR A VALID COMPARISON. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN, DOSE NOT SPECIFIED) AND INSULIN (LEVEMIR, DOSE NOT SPECIFIED) AND IT IS NOT KNOWN WHAT CHANGES, IF ANY, HE MADE TO HIS DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AT THE TIME HE OBTAINED THE ALLEGED INACCURATE BLOOD GLUCOSE RESULTS, HE WAS IN HOSPITAL FOR AN UNRELATED ISSUE AND THAT A FEW MINUTES AFTER OBTAINING THESE RESULTS, HE ¿FAINTED¿. THE PATIENT ADVISED THAT HE WAS TREATED WITH FOOD AND/OR DRINK; HOWEVER, HE WAS UNSURE WHO PROVIDED HIM WITH THE TREATMENT. THE PATIENT ALSO STATED THAT HIS BLOOD GLUCOSE WAS TESTED USING THE HOSPITAL DEVICE AND CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿63 MG/DL¿. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT DEVICE AND THAT AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED ISSUE OCCURRED.