Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 3.9 MMOL/L AND 5.8 MMOL/L ON THE REPORTED METER WITHIN 20 MINUTES. AT THAT TIME, THE PATIENT EXPERIENCED THE SYMPTOMS OF HEADACHE AND IMPAIRED VISION. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD; HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS OCCURRED CONCURRENTLY WITH THE METER READINGS, AND HE DID NOT SEEK ANY MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.