Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN A FEW MONTHS PRIOR TO CONTACTING LFS. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, IN RESPONSE TO THE ALLEGED METER ISSUE THE PATIENT REPORTEDLY CONSUMED MORE FOOD/DRINK; DATE/TIME UNKNOWN. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGE ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AT AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT'S HOME HEALTH/VISITING NURSE REPORTEDLY PERFORMED A BLOOD TESTING (RESULTS UNKNOWN) AND CHECKED HIS HEART, BREATHING, AND VITAL SIGNS. AT THE TIME OF TROUBLESHOOTING (THE CSR VERIFIED THAT AT THE TIME THE ALLEGED ISSUE OCCURRED) THE PATIENT WAS USING THE LFS PRODUCT FOR THE FIRST TIME AND THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE. THE CSR HOWEVER NOTED, THAT THE PATIENT DID NOT HAVE ALL OF HIS TESTING SUPPLIES AVAILABLE. THEREFORE THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.