Description of Event or Problem · 1
ON (B)(6) 2018, A REPORTER FOR THE PATIENT (THE PATIENT¿S DAUGHTER) CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER DISPLAYED BOTH INACCURATELY ERRATIC AND INACCURATELY HIGH RESULTS COMPARED TO THE PATIENT¿S FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION; THE REPORTER WAS UNWILLING TO ANSWER SOME OF THE QUESTIONS AND TERMINATED THE CALL. THE REPORTER CLAIMED THAT THE SUBJECT METER WAS READING INACCURATELY AT AROUND 10:30PM ON (B)(6) 2018, WHEN THE PATIENT OBTAINED ALLEGED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS OF ¿309, 303 AND 313 MG/DL¿, PERFORMED MORE THAN 20 MINUTES APART. THE REPORTED TIME DIFFERENCE OF GREATER THAN 20 MINUTES MAKES THIS COMPARISON INVALID FOR THE PURPOSES OF DETERMINING AN INACCURACY. THE REPORTER ALSO ALLEGED THAT THE RESULTS WERE HIGH COMPARED TO THE PATIENT¿S FEELINGS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE REPORTER WAS UNABLE OR UNWILLING TO SAY WHAT MEDICATIONS THE PATIENT TAKES TO MANAGE HER DIABETES OR WHETHER SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE ALLEGED INACCURATE RESULTS. SHE REPORTED THAT AN UNKNOWN TIME LATER, THE PATIENT DEVELOPED ¿DROWSINESS¿. SHE INDICATED THAT THE PATIENT RECEIVED TREATMENT FOR HER SYMPTOM BUT THE NATURE OF THE TREATMENT WAS NOT PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE REPORTER INDICATED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. THE CCA WALKED THE REPORTER THROUGH A CONTROL SOLUTION TEST AND THE RESULT OF 116 MG/DL FELL WITHIN THE CONTROL SOLUTION RANGE FOR THE VIAL OF 102-138 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, I.E. DROWSINESS AFTER OBTAINING ALLEGED ERRATICALLY HIGH RESULTS ON THE SUBJECT METER.