Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE CONTROL SOLUTION TESTED OUTSIDE OF SPECIFICATIONS ON HIS ONETOUCH VERIO IQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2013. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN AND LANTUS INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE. ON THE FOLLOWING DAY, THE PATIENT CLAIMED HE FELT A SYMPTOM OF HEADACHE. NO TREATMENT WAS SPECIFIED AT THAT TIME. ON THE AFTERNOON OF (B)(6) 2013, THE PATIENT VISITED HIS PHYSICIAN¿S OFFICE AND OBTAINED BLOOD GLUCOSE RESULTS OF ¿197, 212 AND 202 MG/DL¿ WITH THE PHYSICIAN¿S METER. THE PATIENT WAS ADVISED TO ¿OBTAIN NEW TEST STRIPS.¿ LATER THAT SAME EVENING, THE PATIENT REPORTEDLY ADMINISTERED SELF A DECREASED DOSE OF HUMALOG INSULIN (9 UNITS) AND LANTUS INSULIN (39 UNITS). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THE CORRECT CONTROL SOLUTION WAS BEING USED FOR TESTING. THE CCA WALKED THE PATIENT THROUGH ANOTHER CONTROL SOLUTION TEST WHICH TESTED OUTSIDE OF SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOM OF ¿HEADACHE" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THE COMPLAINT IS BEING REPORTED DUE TO THE FAILING CONTROL SOLUTION TEST RESULT.