Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING HER ONE VERIO IQ METER READ INACCURATELY ERRATIC WHEN PERFORMING CONSECUTIVE BLOOD GLUCOSE TESTS. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVES (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN AT 8:00 A. M. ON AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED A READING OF ¿GLYCEMIA TOO HIGH¿ ON THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE, SELF-ADJUSTER) AND STATED SHE TOOK INSULIN (UNKNOWN TYPE AND DOSAGE) IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED SHE RETESTED HER BLOOD GLUCOSE AGAIN AND OBTAINED A READING OF ¿HIGH¿ WITH THE SUBJECT METER. THE PATIENT CLAIMED SHE TOOK ¿MORE INSULIN (UNKNOWN TYPE AND DOSAGE)¿ IN RESPONSE TO THE READING OBTAINED AT THE TIME. THE PATIENT REPORTED, 1 HOUR AFTER TAKING THE INSULIN, SHE DEVELOPED SYMPTOMS OF ¿DIZZY AND SWEATING¿. THE PATIENT CALLED EMERGENCY MEDICAL SERVICES (EMS) AND WHEN THEY ARRIVED TESTED THE PATIENT¿S BLOOD GLUCOSE AND OBTAINED A READING OF ¿0.34 MG/DL¿ WITH THE EMS METER. AT 9:00 A. M., EMS GAVE HER A GLUCAGON INJECTION AND THEN BROUGHT HER TO THE HOSPITAL. THE PATIENT STATED A HEALTH CARE PROFESSIONAL (HCP) GAVE HER ¿SUGAR THROUGH A FEEDING TUBE¿. THE PATIENT MENTIONED THAT ¿SHE CAN ONLY EAT BY A TUBE AND HAS NO PANCREAS ANYMORE¿. DURING TROUBLESHOOTING, THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.