Description of Event or Problem · 1
ON (B)(6) 2019 THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING HER ONE TOUCH VERIOIQ METER DISPLAYED THE ERROR MESSAGE ¿ERROR 2¿. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE FIRST APPEARED ON (B)(6) 2019 AT 6:30 PM. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN ¿1 G¿ AND AMARYL 2 MG) AND CLAIMS SHE ATE HER MEAL AFTER SHE RECEIVED THE ERROR MESSAGE AS SHE ASSUMED THAT HER SUGAR WAS LOW. IMMEDIATELY AFTER SHE RECEIVED THE ERROR MESSAGE ON THE SUBJECT METER, THE PATIENT DEVELOPED SYMPTOMS OF ¿PALPITATING, SWEATING AND FEELING DIZZY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE ALLEGED ISSUE. IT WAS NOT REPORTED IF SHE USED ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE PATIENT USED THE CORRECT TEST STRIPS AND FOLLOWED THE CORRECT TESTING PROCEDURE. THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS NO INDICATION OF MISUSE TO THE DEVICE. AFTER PRESSING THE POWER BUTTON, THE CSR CONFIRMED THAT THE ERROR MESSAGE DOES NOT OCCUR, HOWEVER, THE PATIENT COULD NOT SPECIFY WHETHER THE ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED METER ISSUE BEGAN.