Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIOPRO METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE 6X DAILY AND HIS RESULTS ARE USUALLY AROUND ¿100-170 MG/DL¿ (BEFORE MEALS). THE PATIENT MANAGES HIS DIABETES WITH NOVORAPID INSULIN (SLIDING SCALE) AND INSULATOR INSULIN (20 UNITS IN THE EVENING). THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 954PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿176 AND 362 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. THE PATIENT CLAIMED HE FELT ¿NORMAL¿ AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, THE PATIENT FELT THE RESULTS WERE TOO ELEVATED. NO TREATMENT WAS SPECIFIED DUE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT DENIED DEVELOPING SYMPTOMS. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.