Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT POSTED A CONCERN ON A SOCIAL MEDIA SITE ALLEGING HIS ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND OR NORMAL RESULT AND ANOTHER DEVICE. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION AND CLARIFICATION. THIS COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION THE PATIENT POSTED ON THE SOCIAL MEDIA SITE. ON AN UNSPECIFIED DAY IN (B)(6) 2013, THE PATIENT REPORTED THAT PRIOR TO GOING TO THE GYM HE TESTED WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH READING OF ¿98 MG/DL¿. IT IS NOT KNOWN WHAT MEDICATIONS, IF ANY, THE PATIENT TAKES TO MANAGE HIS DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS DIABETES MEDICATION IN RESPONSE TO THE ALLEGED INACCURATE RESULT. THE PATIENT WROTE THAT HE AT AN ENERGY BAR BEFORE HIS WORKOUT AS HE USUALLY DOES. THE PATIENT REPORTED THAT HALFWAY THROUGH HIS WORKOUT HE BEGAN TO FEEL DIZZY AND STARTED SEEING ¿BRIGHT LIGHTS¿. THE PATIENT REPORTED THAT HE WENT HOME AND WHEN HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER HE OBTAINED A READING OF ¿97 MG/DL¿. THE PATIENT REPORTED THAT HE THEN TESTED WITH ANOTHER DEVICE (COUNTOUR METER) AND OBTAINED A RESULT OF ¿58 MG/DL. THE PATIENT WROTE THAT HE ATE SOMETHING AFTER TESTING WITH THE OTHER DEVICE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30 MG/DL. ALTHOUGH THE PATIENT TREATED HIMSELF WITH FOOD AND/OR DRINK, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENTS REPORTED SYMPTOMS OR BLOOD GLUCOSE READINGS DO NOT MEET LFS¿ CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.