Description of Event or Problem · 1
ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT AT 8:30PM ON (B)(6) 2018, SHE OBTAINED A BLOOD GLUCOSE RESULT OF ¿83 MG/DL¿ ON THE SUBJECT METER WHICH SHE FELT WAS FINE FOR HER. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. SHE INDICATED THAT AFTER OBTAINING THE RESULT, SHE FELT FINE AND DID NOT TAKE ANY ACTION. SHE REPORTED THAT ABOUT 15-20 MINUTES LATER, SHE ¿LOST CONSCIOUSNESS/PASSED OUT¿. SHE STATED THAT HER HUSBAND CALLED THE EMERGENCY MEDICAL SERVICES (EMS). SHE INDICATED THAT WHEN THE EMS ARRIVED, AROUND 9PM ON (B)(6) 2018, THEY OBTAINED A BLOOD GLUCOSE RESULT OF ¿48 MG/DL¿ ON THEIR METER. THE PATIENT REPORTED THAT SHE WAS GIVEN ¿IV FLUIDS¿ BY THE EMS TO TREAT HER SYMPTOMS; SHE SPECIFICALLY STATED THAT SHE DID NOT RECEIVE IV GLUCOSE OR A GLUCAGON INJECTION. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT HER METER WAS SET TO THE CORRECT UNIT OF MEASURE AND HER TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE WITHIN EXPIRY DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TEST TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS, INCLUDING CONTROL SOLUTION, WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, I.E. LOST CONSCIOUSNESS AND PASSED OUT REQUIRING EMS INTERVENTION OF UNKNOWN IV FLUIDS, AFTER OBTAINING AN ALLEGED INACCURATE BLOOD GLUCOSE RESULT ON THE SUBJECT METER.