Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/PATIENT'S FATHER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT'S ONETOUCH SELECT SIMPLE METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE PATIENT'S FATHER REPORTED THAT ON (B)(6) 2012 AT APPROXIMATELY 7AM, THE PATIENT WAS TESTED WITH THE SUBJECT METER AND OBTAINED A READING OF "73 MG/DL." DURING THE FOLLOW-UP CALL, THE REPORTER INFORMED THE CSR THAT THE PATIENT'S BLOOD GLUCOSE GENERALLY FELL IN THE "90-110 MG/DL" RANGE. THE PATIENT'S FATHER STATED THAT THE PATIENT TAKES A SET DOSE OF 10 UNITS OF INSULIN (TYPE UNKNOWN) EVERY DAY IN THE MORNING. THE PATIENT'S FATHER CONFIRMED THAT THE PATIENT WAS ADMINISTERED HER USUAL DOSE OF INSULIN AFTER HAVING TESTED HER BLOOD GLUCOSE. THE PATIENT'S FATHER CLAIMED THAT APPROXIMATELY 5 MINUTES AFTER TESTING WITH THE SUBJECT METER THE PATIENT WENT INTO "CONVULSIONS." THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY OTHER SYMPTOMS PRIOR TO HAVING THE "CONVULSIONS." THE PATIENT'S FATHER STATED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED WITH IV GLUCOSE AND HOSPITALIZED FOR A COUPLE OF DAYS. THE REPORTER STATED THE PATIENT'S ADMITTING DIAGNOSIS WAS HYPOGLYCEMIA. THE PATIENT'S FATHER CONFIRMED THE PATIENT'S BLOOD GLUCOSE WAS TESTED WITH A HOSPITAL METER AT THE TIME OF HER ARRIVAL; HOWEVER, THE PATIENT'S FATHER DID NOT KNOW WHAT THE READING WAS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THE REPORTER INFORMED THE CSR DURING THE FOLLOW-UP CALL, THAT IF THE SUBJECT METER HAD READ LOWER THAN "73 MG/DL" HE WOULD HAVE GIVEN HER SOMETHING TO EAT AND HAVE WAITED FOR HER BLOOD GLUCOSE TO HAVE INCREASED PRIOR TO ADMINISTERING HER USUAL DOSE OF INSULIN. HOWEVER, BECAUSE HE DID NOT FEEL HER BLOOD GLUCOSE LEVEL WAS LOW, HE ADMINISTERED HER USUAL DOSE OF INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED AND HOSPITALIZED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.