Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS REVERTING TO SET UP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6) 2014, AT 10:00AM. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿BEING NERVOUS, BODY WAS TREMBLING¿, IMMEDIATELY AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED METER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS BEING USED FOR THE FIRST TIME. THE CSR DOCUMENTED THERE WAS NO INDICATION OF MISUSE OF THE PRODUCT. THE CSR WALKED THROUGH RESOLVING THE ISSUE AND THE ALLEGED METER ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED PRODUCT ISSUE BEGAN.