Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED HER FEELINGS AND OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 BETWEEN ¿9-10 P. M.¿ AT UNSPECIFIED DATES/TIMES, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿EXTREME HI, 162, 162 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE; SELF-ADJUSTER). ON (B)(6) 2014 BETWEEN ¿9:00 P. M. TO 2:00 A. M.¿ THE PATIENT STATED SHE HAD MORE FOOD/DRINK IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED, 1 HOUR AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿LOW BLOOD SUGAR¿. THE PATIENT SELF-TREATED BY EATING A JELLY SANDWICH. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND IT FELL WITHIN THE APPROPRIATE CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.