Description of Event or Problem · 1
ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN EARLY (B)(6) 2013. IT WAS REPORTED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "400 MG/DL" WITH THE SUBJECT METER AND "90 MG/DL" ON ANOTHER METER, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. A COUPLE WEEKS AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT A SYMPTOM OF DIZZY. THE REPORTER DENIED THE PATIENT RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH QUALITY CONTROL TESTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOM OF "DIZZY" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE REPORTER ALSO DENIED THE PATIENT RECEIVED TREATMENT AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS'S ACCURACY CRITERIA.