Description of Event or Problem · 1
ON MARCH 5, 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA 2 METER HAD AN "ERROR 4" ISSUE. THE PATIENT TESTS HER BLOOD GLUCOSE 6-8 TIMES A DAY. DURING THE TIME OF CONCERN, THE PATIENT WAS ON A DIABETES MANAGEMENT REGIMEN CONSISTING OF TAKING SLIDING-SCALE NOVOLOG INSULIN BASED ON HER METER READINGS. THE REPORTER INDICATED THAT THE ALLEGED METER ISSUE STARTED IN 2008, AT AROUND 6:00 PM. SHE COULD NOT RECALL WHAT METER READINGS THE PATIENT GOT EARLIER IN THE DAY, BEFORE THE ISSUE BEGAN. AT 6:00 PM THAT DAY, THE PATIENT TRIED TO TEST HER BLOOD GLUCOSE BUT ENCOUNTERED THE "ERROR 4" MESSAGE SEVERAL TIMES. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION AND FEELING TIRED. THE REPORTER MENTIONED THAT THE PATIENT TYPICALLY HAS THOSE SYMPTOMS WHEN HER BLOOD GLUCOSE IS "TOO HIGH." THE REPORTER THEN TREATED THE PATIENT WITH AN "AVERAGE DOSE" OF 1 UNIT NOVOLOG INSULIN. THE REPORTER ATTEMPTED TO CALL LFS FOR ASSISTANCE BUT DISCONNECTED WHILE SHE WAS ON HOLD. THE REPORTER EXPLAINED THAT SHE HAD TO GO TO A LOCAL PHARMACY TO PURCHASE ANOTHER METER, SINCE SHE WANTED TO CHECK THE PATIENT'S BLOOD GLUCOSE RIGHT AWAY. ABOUT 3 HOURS AFTER THE REPORTED METER ISSUE BEGAN, THE REPORTER WAS ABLE TO PURCHASE A ONE TOUCH ULTRA METER AND TEST THE PATIENT'S BLOOD GLUCOSE. BY THAT TIME, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS "76 MG/DL." THE PATIENT DID NOT SEEK OR RECEIVE MEDICAL ATTENTION FROM A HEALTH CARE PROVIDER. THREE DAYS LATER, THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR. THE PATIENT'S DOCTOR DISCONTINUED THE PATIENT'S NOVOLOG INSULIN REGIMEN AND PRESCRIBED LANTUS INSULIN. THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE METER WAS NOT EXPOSED TO AN UNACCEPTABLE OPERATING TEMPERATURE RANGE. THE TEST STRIPS WERE ALSO DESCRIBED AS BEING IN GOOD CONDITION. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.