Description of Event or Problem · 1
ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN DURING THE NIGHT OF AN UNSPECIFIED DATE. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿221, 399, 280 AND 340 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH INSULIN (LANTUS SOLOSTAR; DOSE UNKNOWN) AND DENIED TAKING ANY ACTION IN REGARDS TO HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ELEVATED RESULTS. THE PATIENT REPORTED DEVELOPING SYMPTOM OF ¿SWEATING¿ APPROXIMATELY THREE AND A HALF HOURS AFTER THE ALLEGED ISSUE BEGAN, BUT DENIED RECEIVING ANY TREATMENT. THE PATIENT DENIED THAT HIS BLOOD GLUCOSE WAS TESTED ON ANY OTHER DEVICE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING ALLEGED INACCURATE HIGH RESULTS WITH THE SUBJECT METER.