Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT SHE OBTAINED AN UNKNOWN ERROR MESSAGE WITH HER ONETOUCH VERIOIQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE APPEARED EITHER IN (B)(6) OF 2013. THE PATIENT INFORMED THE CSR THAT THE ERROR INCLUDED SOME INFORMATION THAT THERE WAS 'SOMETHING WRONG WITH THE TEST STRIP." AT THE TIME OF THE CALL, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF "SHAKY, PALE, TIRED, FEVER, VERY EXHAUSTED" ON AN UNSPECIFIED DATE AFTER THE ALLEGED METER ISSUE STARTED. THE CSR NOTED THAT THE PATIENT DECLINED TO ANY ADDITIONAL QUESTIONS. IT IS NOT KNOWN WHAT MEDICATIONS THE PATIENT WAS TAKING TO MANAGE HER DIABETES AT THE TIME THE ALLEGED ISSUE STARTED. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO NOT BEING ABLE TO TEST WITH THE SUBJECT METER. IN ADDITION, IT IS NOT KNOWN WHAT TREATMENT THE PATIENT RECEIVED IN RESPONSE TO THE SYMPTOMS SHE DEVELOPED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT CLAIMED SHE NO LONGER HAD THE SUBJECT METER. THE PATIENT REPORTED THAT A FEW WEEKS PRIOR TO CONTACTING LFS SHE WENT TO A PHARMACY AND THE PHARMACIST REPLACED THE SUBJECT METER WITH ANOTHER DEVICE (BAYER CONTOUR). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE STARTED.