Description of Event or Problem · 1
ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIO2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON LFS'S CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS NOT ABLE TO SAY WHEN THE REPORTED ISSUE WITH THE METER STARTED. HE CLAIMED THAT ON DATE/TIME UNKNOWN HE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS ON THE SUBJECT METER OF "142, 147, 144, 140, 147, 137, 137, 161, 145, 104, 104, 112, 107 AND 175 MG/DL, COMPARED TO "114, 123, 109, 113, 111, 123, 111, 127, 113, 92, 101, 104, 102 AND 124 MG/DL" ON A ONETOUCH ULTRAEASY METER, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE REPORTED DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE LFS'S ACCURACY CRITERIA. THE PATIENT MANAGES HIS DIABETES WITH INSULIN. HE REPORTED THAT IN RESPONSE TO THE RESULTS HE OBTAINED ON THE SUBJECT METER, HIS DOCTOR ADVISED HIM TO INCREASE HIS MEDICATION. HE WAS UNABLE OR UNWILLING TO SAY WHETHER HE DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE. HE REPORTED, HOWEVER, THAT AFTER COMPARING RESULTS ON THE SUBJECT METER WITH THE ONETOUCH ULTRAEASY METER, HE CHANGED HIS MEDICATION BACK TO THE ORIGINAL DOSE. AT THE TIME OF TROUBLESHOOTING, THE ISSUE REMAINED UNRESOLVED. THE PATIENT REFUSED A REPLACEMENT METER. IN CONCLUSION, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA NOR RECEIVE MEDICAL INTERVENTION FOR THIS CONDITION. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.