Description of Event or Problem · 1
ON APRIL 25, 2006 THE LAY REPORTER, THE LAY PATIENT'S WIFE, CONTACTED LIFESCAN ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER WAS PROMPTING THE APPLY SAMPLE ICON. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT THREE DAYS LATER TO OBTAIN/VERIFY THE FOLLOWING INFORMATION: THE PATIENT ATTEMPTED TO TEST WITH THE REPORTED METER AND WAS UNABLE TO OBTAIN A RESULT FOR ONE MONTH. THE PATIENT SAID THE METER GAVE THE APPLY SAMPLE, ERRO 2, AND ERRO 5 MESSAGES. THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF AVANDARYL, ONE PILL PER DAY. AT 9:00AM ON APRIL 25, 2006 THE PATIENT'S WIFE CALLED EMS BECAUSE THE PATIENT WAS "DOPEY, AND CONFUSED". WHEN EMS ARRIVED, A RESULT OF 23 MG/DL WAS OBTAINED ON THE EMS DEVICE. EMT'S STARTED AN IV; THE PATIENT SAID HE IMMEDIATELY FELT BETTER AFTER BEING TREATED WITH THE IV. HE WAS NOT TAKEN TO THE HOSPITAL. FOLLOWING THE INCIDENT, THE PATIENT'S PHYSICIAN INSTRUCTED THE PATIENT TO TEST HIS BLOOD GLUCOSE DAILY AND CALL THE PHYSICIAN IF HIS BLOOD GLUCOSE LEVEL BECAME LOW OR ELEVATED. THE PHYSICIAN CHANGED THE PATIENT'S ORAL DIABETES MEDICATION; HOWEVER, THE PATIENT DID NOT RECALL THE NAME AND DOSE OF THE NEW MEDICATION. THE CUSTOMER SERVICE AGENT (CSA) WALKED THE WIFE THROUGH ATTEMPTING TO TEST WITH A NEW TEST STRIP FROM A NEW VIAL OF TEST STRIPS; THE TEST DID NOT START WITH EITHER ATTEMPT. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE PATIENT EXPERIENCED HYPOGLYCEMIA REQUIRING MEDICAL INTERVENTION.