Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT¿S DAUGHTER IN LAW (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING AN UNKNOWN ISSUE WITH HER MOTHER IN LAW¿S LANCING DEVICE. THE BRAND AND TYPE OF LANCING DEVICE ARE NOT KNOWN. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER DOES NOT KNOW WHEN THE PRODUCT ISSUE FIRST BEGAN. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE REPORTER STATED THE PATIENT ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE. THE PATIENT REPORTEDLY DID NOT TAKE ANY ACTION IN RESPONSE TO THE PRODUCT ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT ALLEGEDLY DEVELOPED A SYMPTOM OF SHAKING AND FELT NERVOUS. IT IS NOT KNOWN IF THE PATIENT ADMINISTERED ANY TREATMENT AFTER THE PRODUCT ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE REPORTER HAS NO IDEA WHICH DEVICE IS BEING USED AND NO LONGER HAS THE SUBJECT LANCING DEVICE AVAILABLE. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. ALTHOUGH IT CANNOT BE CONFIRMED WHAT BRAND AND TYPE OF LANCING DEVICE THE PATIENT WAS USING AT THE TIME THE ALLEGED ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.