Description of Event or Problem · 1
THE LAY USER/PATIENT CALLED LIFESCAN (LFS) IN MARCH 2006, AND ALLEGED THAT HIS METER WAS READING INACCURATELY HIGH. THE LFS REPRESENTATIVE CONTACTED THE PT AND OBTAINED FURTHER CLARIFICATION. ON FEBRUARY 16, 2006, AT 8:43 A.M., THE PT OBTAINED A RESULT OF 7.9 MMOL/L. HE TOOK HIS SET AMOUNT OF 24 UNIT OF HIS "SHORT-TERM INSULIN". AT 1:54 P.M., HE OBTAINED A RESULT OF 5.0 MMOL/L AND HE TOOK HIS SET AMOUNT OF 12 UNITS OF HIS "SHORT-TERM" INSULIN. AT 8:56 P.M. HE OBTAINED A RESULT OF 7.6 MMOL/L. HE REPORTED NO SYMPTOMS AT THE TIME OF TESTING. AT APPROXIMATELY 10:00 P.M. HE INJECTED 12 UNITS OF HIS LONG-TERM INSULIN AND WENT TO SLEEP. AT APPROXIMATELY 2:00 A.M. HIS WIFE WOKE UP, BECAUSE SHE HEARD THE PATIENT SPEAKING IN HIS SLEEP. HE WAS SWEATING PROFUSELY AND WAS NOT RESPONSIVE. HE WAS UNCONSCIOUS, SO HIS WIFE CALLED THE PARAMEDICS. THEY PERFORMED AN ELECTROCARDIOGRAM BUT DID NOT CHECK HIS BLOOD GLUCOSE. HE WAS HOSPITALIZED WITH SUSPICION OF APOPLEXY (POSSIBLE HEMORRHAGING). AT APPROXIMATELY 3:00 A.M., IN THE HOSPITAL THEY OBTAINED A RESULT OF 2.0 MMOL/L. HE WAS HOSPITALIZED FOR A FEW DAYS AND DURING THIS TIME HE COMPARED HIS METER TO THE LABORATORY. THE COMPARISON RESULTS ARE: ULTRA 10.1 MMOL/L TO THE LAB 6.1 MMOL/L, ULTRA 15.4 MMOL/L TO THE LAB 12.1 MMOL/L, AND ULTRA 7.3 MMOL/L TO THE LAB 4.0MML/L. THE PATIENT DID NOT HAVE ANY OF HIS TESTING SUPPLIES AVAILABLE TO TROUBLESHOOT. HE DID REPORT THAT THE TECHNIQUES FOR CLEANING THE PUNCTURE SITE AND FOR APPLYING THE BLOOD TO THE TEST STRIP WERE CORRECT. A REPLACEMENT METER HAS BEEN SENT.