Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY 4 YEARS AGO, EXACT DATE/TIME IS NOT KNOWN. THE PATIENT REPORTEDLY TESTED ON THE SUBJECT METER AND OBSERVED AN INACCURATE HIGH RESULT AS COMPARED TO HIS NORMAL READINGS/FEELINGS. HE REPORTED THAT HIS NORMAL BLOOD GLUCOSE READINGS IS AROUND 100MG/DL. THE PATIENT COULD NOT RECALL WHAT THE HIGH RESULT WAS 4 YEARS AGO. THE PATIENT REPORTEDLY TEST 3-4 TIMES PER DAY AND MANAGES HIS DIABETES WITH ACTRAPID INSULIN, 24 + UNITS BASED ON HIS METER READINGS. THE PATIENT RECALLED ADMINISTERING 24 UNITS OR MORE OF ACTRAPID INSULIN BASED ON THE HIGH RESULT. APPROXIMATELY 2.5 HOURS LATER, HE DEVELOPED SYMPTOMS OF SHAKING AND SWEATING. HE TESTED USING THE SUBJECT METER AND OBTAINED A READING OF ¿60-70 MG/DL¿ AT THE ONSET OF HIS SYMPTOMS. THE PATIENT REPORTEDLY SELF-TREATED WITH GLUCOSE TABLETS, DRANK (B)(4) AND FELT BETTER WITHIN 30 MINUTES TO AN HOUR. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING THE CSR CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE PATIENT DID NOT HAVE THE METER OR TESTING SUPPLIES ANY LONGER. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.