Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER 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). AT AN UNSPECIFIED TIME ON (B)(6) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READINGS OF '103MG/DL' WITH THE SUBJECT METER AND WITHIN 30 MINUTES, FOR REASON UNKNOWN, THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND THE PATIENT OBTAINED A READING OF '40MG/DL' WITH THE EMS'S METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT'S TESTING FREQUENCY IS NOT KNOW, HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER) AND ON THE MORNING OF (B)(6), THE PATIENT HAD REPORTEDLY CONTINUED WITH HIS USUAL DOSE OF MEDICATION. THE PATIENT'S BLOOD GLUCOSE READING (WITH THE SUBJECT METER) PRIOR TO ADMINISTERING HIS USUAL DOSE OF INSULIN IS NOT KNOWN. IT IS ALSO NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO HIS REPORTED RESULT ('103MG/DL'). THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, ON (B)(6) (BEFORE 12PM) THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION(BY A HEALTH CARE PROFESSIONAL). IT IS NOT CLEAR IF THE PATIENT RETESTED WITH THE SUBJECT METER AFTER RECEIVING TREATMENT AND IT IS NOT SPECIFIED IF THE PATIENT REQUIRED ADDITIONAL MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE.THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT'S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.