Description of Event or Problem · 1
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY OCCURRED ON AN UNSPECIFIED DATE 3 WEEKS PRIOR TO THE ALERT DATE OF (B)(6) 2017. AT THIS TIME, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿211, 113 AND 130MG/DL¿ WITH THE SUBJECT METER WHICH THEY FELT WERE HIGHER THAN THEIR FEELINGS AND/OR NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE THEIR DIABETES, BUT THE PATIENT REPORTED THAT THEY DECREASED THEIR FOOD AND DRINK INTAKE AS A RESULT OF THE ALLEGED PRODUCT ISSUE 3 WEEKS AGO. THE PATIENT REPORTED THAT ON (B)(6) 2017 WHEN THEY WOKE UP THEY HAD A ¿TERRIBLE HEADACHE¿; WHICH THEY HAD TO SEEK MEDICAL ADVICE FOR OVER THE TELEPHONE. THE ADVICE WHICH THE PATIENT RECEIVED FROM THE HEALTHCARE PROFESSIONAL WAS TO CONSUME SOME CANDY. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING ALLEGEDLY INACCURATE HIGH RESULTS WITH THE SUBJECT METER.