Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY OCCURRED AT 5:30AM ON (B)(6) 2017. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿173, 402 AND 205MG/DL¿ WITH THE SUBJECT METER WITHIN 20 MINUTES OF ONE ANOTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS¿ CRITERIA FOR PRECISION. THE PATIENT MANAGES THEIR DIABETES WITH AN UN SPECIFIED DOSAGE OF METFORMIN AND TOOK AN INCREASED DOSAGE OF THIS MEDICATION (DOSAGE UNSPECIFIED) IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT DID NOT DEVELOP ANY PHYSICAL SYMPTOMS OR REQUIRE ANY FURTHER TREATMENT AS A RESULT OF THIS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ADVERSE EVENT. THE PATIENT DID NOT DEVELOP SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR AN ACUTE BLOOD GLUCOSE EXCURSION. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE CALCULATED DIFFERENCE BETWEEN THE REPORTED RESULTS FALLS OUTSIDE LFS¿ PRECISION CRITERIA AND THE ALLEGED INACCURACY WAS NOT RESOLVED DURING TROUBLESHOOTING.