Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO THE EMERGENCY MEDICAL SERVICE'S DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN FIVE TO SIX MONTHS PRIOR TO CONTACTING LFS. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ACCORDING TO THE CSR'S DOCUMENTATION, APPROXIMATELY SIX MONTHS PRIOR TO CONTACTING LFS, THE PATIENT INDICATED SHE HAD PASSED OUT (DATE/TIME UNKNOWN). THE PATIENT'S BLOOD GLUCOSE READING PRIOR TO THE PASSING OUT IS NOT KNOWN, IT IS NOT CLEAR WHAT ACTION HAD TAKEN IN RESPONSE TO THE READING, IT IS NOT KNOWN HOW LONG AFTER PASSING OUT THE PATIENT REGAINED CONSCIOUSNESS, AND IT IS NOT SPECIFIED IF THE PATIENT RECEIVED ANY TREATMENT AFTER SHE HAD PASSED OUT. ON (B)(6) 2012 (AT 9:14AM) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "44MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. THE REASON PATIENT DID NOT TAKE ANY ACTION IN RESPONSE TO THE REPORTED READING ("44MG/DL") IS NOT CLEAR AND IT IS NOT CLEAR IF THE PATIENT WAS SYMPTOMATIC PRIOR TO OR IF THE PATIENT DEVELOPED ANY SYMPTOMS AFTER OBTAINING HER REPORTED RESULT. APPROXIMATELY 45 MINUTES AFTER OBTAINING THE READING OF "44MG/DL" WITH THE SUBJECT METER, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING BELOW "20MG/DL" WITH THE EMS'S METER AND WAS LATER REPORTEDLY TRANSPORTED TO THE EMERGENCY ROOM (ER).ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT AROUND "50MG/DL" WITH THE ER'S METER AND WAS ADMINISTERED FOOD/DRINK AS TREATMENT. IT IS NOT KNOWN WHEN THE PATIENT WAS RELEASED FROM THE ER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDING: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY MAY HAVE DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.