Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN IN NOVEMBER 2012. THE PATIENT REPORTED RESULTS OF ¿13.6, 13.1, 24.9, 19, 18.8 MMOL/L¿ WITH THE SUBJECT METER AND ¿9.3, 8.9, 18.9, 14.4 AND 11.7 MMOL/L¿ WITH ANOTHER DEVICE, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO METER ACCURACY TESTING. IT IS NOT SPECIFIED HOW THE PATIENT MANAGES HIS DIABETES; HOWEVER, BASED ON THE ALLEGED HIGH RESULTS, THE PATIENT REPORTEDLY INCREASED HIS INSULIN DOSE (AMOUNT NOT SPECIFIED). AFTER, THE PATIENT CLAIMED HE WOULD HAVE ¿HYPOS MAINLY IN HIS SLEEP.¿ SYMPTOMS WERE NOT SPECIFIED. THE PATIENT DID NOT SPECIFY RECEIVING MEDICAL TREATMENT. 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. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.