Description of Event or Problem · 0
ON (B)(6) 2023, THE PATIENT CALLED LIFESCAN (LFS) US ALLEGING THAT THEIR ONETOUCH DELICA PLUS LANCING DEVICE WOULD NOT FIRE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT STATED THAT THEY HAD A OT DELICA PLUS LANCING DEVICE THAT WOULD NOT FIRE. THE PATIENT ALSO STATED AT THE TIME OF THE CALL THAT THEY HAD A ¿BAD HEADACHE¿ BUT IT IS NOT CLEAR WHETHER THE DEVICE ISSUE CAUSED OR CONTRIBUTED TO THIS. THE PATIENT NORMALLY TREATS THEIR DIABETES WITH PILLS AND DIET AND/OR EXERCISE (SPECIFIC DETAILS NOT PROVIDED). ATTEMPTS WERE MADE TO CALL THE PATIENT FOR CLARIFICATION ON THE SYMPTOMS AND ACTIONS THAT THE PATIENT TOOK FOLLOWING THE SYMPTOMS HOWEVER THESE WERE UNSUCCESSFUL AS THE PATIENT COULD NOT BE REACHED. DURING TROUBLESHOOTING, THE CCA DETERMINED THAT THE PATIENT WAS USING THE CORRECT LANCETS FOR THE DEVICE, WERE USING THE CORRECT TECHNIQUE AND THAT THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT. ALTHOUGH THERE ARE FEW DETAILS FOR THIS ALLEGED INCIDENT, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SIGNS/SYMPTOMS THAT COULD BE SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AND THE SUBJECT DEVICE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.