Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH VERIO2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA. THE PATIENT ALLEGED THAT THE SUBJECT METER WAS READING INACCURATELY HIGH AT 5:30 AM ON (B)(6) 2017; HOWEVER, NO RESULTS WERE PROVIDED FOR THIS TIME. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN MEDICATION. SHE REPORTED THAT SHE HAD CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE ALLEGED INACCURATE RESULT. SHE REPORTED THAT TWO AND A HALF HOURS LATER, SHE DEVELOPED SYMPTOMS OF ¿SHAKINESS, FELT FAINT LIKE PASSING OUT AND DIZZY¿. SHE REPORTED THAT SHE SELF-TREATED HER SYMPTOMS BY CONSUMING FOOD AND DRINK AT 8:30 AM. SHE REPORTED THAT AT 9:30 AM ON (B)(6) 2017, SHE PERFORMED A COMPARISON BETWEEN THE SUBJECT METER AND HER HUSBAND¿S METER AND OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF ¿191 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿141 MG/DL¿ ON HER HUSBAND¿S ONETOUCH VERIO2 METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DESCRIBED THE CORRECT TEST STEPS AND INDICATED THAT SHE HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. THE CCA NOTED THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY AND THE TEST STRIP VIAL WAS INTACT. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT OF 119 MG/DL FELL WITHIN THE EXPECTED RANGE OF 102-138 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.