Description of Event or Problem · 1
ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT¿S ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 9AM. IT WAS REPORTED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿150 MG/DL¿ WITH THE SUBJECT METER (USUALLY ¿100 MG/DL¿ IN THE MORNING). THE PATIENT MANAGES HIS DIABETES WITH METFORMIN PILLS. BASED ON THE ALLEGED RESULT AND PER THE ADVICE OF HIS HEALTH CARE PROFESSIONAL (HCP), THE PATIENT INCREASED HIS USUAL DOSE OF METFORMIN PILLS (AMOUNT NOT SPECIFIED). THE PATIENT WAS ADVISED TO INCREASE HIS USUAL DOSE OF METFORMIN PILLS WHEN HIS BLOOD GLUCOSE READS ¿OVER 140 MG/DL.¿ AFTER, THE REPORTER ALLEGED THE PATIENT FELT ¿ILL.¿ THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF WEAK, WITHOUT ENERGY AND DIZZY. THE PATIENT ATE SUGAR AS TREATMENT AND FELT BETTER AFTER. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY REMAINED UNRESOLVED. THE PATIENT'S TREATMENT DID NOT CORRELATE WITH THE ALLEGED HIGH READING HE OBTAINED ON THE SUBJECT METER.