Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOPRO METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013 AT 10:15 PM. THE PATIENT REPORTEDLY OBTAINED RESPECTIVELY BLOOD GLUCOSE READINGS OF "164, 132, AND 147 MG/DL" WITH THE SUBJECT METER AND "132, 81, 112 MG/DL" WITH THE ONETOUCH ULTRAEASY METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT MANAGES HER DIABETES WITH LANTUS INSULIN (SELF ADJUSTER). ACCORDING TO THE CSR'S DOCUMENTATION, AT THE SAME TIME AFTER THE ALLEGED METER ISSUE OCCURRED THE PATIENT REPORTEDLY ADMINISTERED A LESSER DOSE OF INSULIN (6 UNITS INSTEAD OF 8 UNITS). THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGED METER ISSUE. 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. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.