Description of Event or Problem · 1
ON (B)(4) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 5:23 PM. HE TESTED ON THE SUBJECT METER AND OBSERVED VALUES OF 552, 641, 527 MG/DL WHICH HE FELT WERE HIGHER THAN HIS USUAL READINGS/FEELINGS. IT IS NOT KNOWN WHAT RANGE THE PATIENT CONSIDERS TO BE NORMAL. THE PATIENT MANAGES HIS DIABETES WITH 70 UNITS OF LANTUS AND AMARYL PILLS 2 MG AND DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 30 MINUTES AFTER TESTING, HE CLAIMED HE DEVELOPED SYMPTOMS OF SHAKING, VISION PROBLEMS AND DIFFICULTY IN WALKING. HE SELF TREATED HIS SYMPTOMS WITH GLUCOSE TABS/GEL AT APPROXIMATELY 5:53 PM THAT SAME EVENING. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.