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 HER FEELINGS AND/OR NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT 5:20 P.M. THE PATIENT CLAIMED THAT SHE OBTAINED A BLOOD GLUCOSE RESULT OF "110 AND 108 MG/DL" WITH THE SUBJECT METER. THE PATIENT SAID THAT SHE MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE PATIENT DENIED DEVELOPING SYMPTOMS AS RESULT OF THE ALLEGED ISSUE. HOWEVER, THE PATIENT INFORMED THE CCA THAT SHE TREATED HERSELF WITH FOOD AND/OR DRINK AT 5:33 P.M. ON (B)(6) 2012. THE PATIENT DENIED USING ANOTHER DEVICE TO TEST HER BLOOD GLUCOSE. DURING TROUBLESHOOTING THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE PATIENT WAS NOT USING EXPIRED TEST STRIPS. THE PATIENT DID NOT HAVE CONTROL SOLUTION DURING TROUBLESHOOTING TO PERFORM A CONTROL TEST. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. HOWEVER, REPLACEMENT PRODUCT WAS STILL SENT TO THE PATIENT. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE THE PATIENT DENIED DEVELOPING SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE AND THE REPORTED TREATMENT COINCIDES WITH THE ALLEGATION. IN ADDITION, THERE IS NO EVIDENCE THAT THE SUBJECT METER MALFUNCTIONED BASED ON CCA TROUBLESHOOTING. LIFESCAN (LFS) RECEIVED THE METER AND TEST STRIPS INVOLVED WITH THE COMPLAINT. LFS HAS COMPLETED DEVICE EVALUATION WITH THE RETURNED PRODUCTS ON (B)(4) 2012, RESPECTIVELY. INVESTIGATION DID NOT CONFIRM THE ALLEGED COMPLAINT WITH THE RETURNED METER; HOWEVER, THE RETURNED TEST STRIPS FAILED TESTING. INVESTIGATION FOUND THAT THE CONTROL SOLUTION TEST WAS ABOVE EXPECTED RANGE WITH THE RETURNED TEST STRIPS. THIS COMPLAINT IS NOW BEING REPORTED DUE TO THE FAILED TEST STRIPS TEST.