Description of Event or Problem · 1
ON (B)(6), 2010, THE REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING THAT A ONE TOUCH ULTRA METER READ INACCURATELY HIGH. THE REPORTER INDICATED THAT THE ALLEGED ISSUE STARTED ON AN UNSPECIFIED DATE/TIME 6 MONTHS PRIOR TO CONTACTING LFS ON (B)(6), 2010. THE REPORTER REPORTED UNSPECIFIED METER READINGS IN THE "300'S" AND "400'S" MG/DL. AS A RESULT OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT HAD DEVELOPED SYMPTOMS AFTER USING THE DEVICE. IN SOME CASES, THE REPORTER CLAIMED THAT THE PATIENT OBTAINED UNKNOWN HIGH READINGS AND WAS FEELING LIGHT-HEADED, DIZZY, AND SHAKY. IT IS UNCLEAR IF THE PATIENT DEVELOPED THE SYMPTOMS BEFORE OR AFTER THE OBTAINING THE HIGH READINGS. WHEN THE PATIENT FELT LOW, HE REPORTEDLY ADMINISTERED SELF-TREATMENT BY EATING FOOD AND/OR DRINKING A BEVERAGE. THE REPORTER ALSO REPORTED UNSPECIFIED METERS IN THE "70'S" AND "80'S" MG/DL. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT METER READINGS THE PATIENT OBTAINED PRIOR TO DEVELOPING THE SYMPTOMS, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THE REPORTER DID NOT HAVE THE METER OR SUPPLIES FOR TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER USING THE REPORTED METER.