Description of Event or Problem · 1
A HOSPITAL REPRESENTATIVE CONTACTED LIFESCAN IN 2005 ALLEGING THAT , BEAUSE THE METER USED IN THE FACILITY CONTAINED MISSING SEGMENTS, A PATIENT WAS INAPPROPRIATELY TREATED AND SUBSEQUENTLY DIED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THE PATIENT WAS IN THE HOSPITAL FOR DIABETES CARE IN 2005 A NURSE TESTED PATIENT'S BLOOD GLUCOSE AND READ THE RESULT AS 1.1 MMO/L". THE PATIENT WAS GIVEN IV GLUCOSE BASED ON THE METER'S RESULT. NO OTHER BLOOD GLUCOSE TESTING WAS PERFORMED ON PATIENT THAT DAY. "THE NEXT DAY", PRESUMABLY 07/2005, THE PATIENT SUFFERED HEART FAILURE AND THEN DIED. WHEN THE PATIENT SUFFERED HEART FAILURE, A PHYSICIAN TESTED THEIR GLUCOSE ON ANOTHER SURESTEP METER RESULT. "HI" (GREATER THAN 33.3 MMO/L OR 500 MG/DL). THE PHYSICIAN WOULD NOT PROVIDE THE TIME OF THE HI RESULT IN RELATION TO TIME OF DEATH. QUESTIONING THE ACCURACY OF THE SURESTEP WITH THE 1.1 MMO/L RESULT THE PHYSICIAN TOOK IT TO THE DISTRIBUTOR, WHO DISCOVERED THAT ITS MEMORY CONTAINED THREE "HI" RESULTS, RATHER THAN A 1.1 MMO/L DURING "THE EXACT TIME THAT THE TEST WAS TAKEN". BASED ON THIS INFORMATION, THE PHYSICIAN ASSUMED THE SEGMENTS WERE MISSING. THE HOSPITAL STAFF WAS UNWILLING TO PROVIDE THE FOLLOWING DETAILS. SPECIFIC REASON FOR THEIR HOSPITALIZATION FOR DIABETES - WHAT, IF ANY, SYMPTOMS THE PATIENT EXPERIENCED AT THE TIME OF THE "1.1 MMO/L" RESULT SYMPTOMS OF HYPOGLYCEMIA WOULD BE EXPECTED AT THIS LOW GLUCOSE VALUE. EVEN IF THE PATIENT HAD HYPOGLYCEMIC UNAWARENESS, AND WE HAVE NO INFORMATION THAT PATIENT DID THEY WOULD BE EXPECTED TO HAVE CENTRAL NERVOUS SYSTEM SYMPTOMS, INCLUDING EVEN COMA OR SEIZURE, AT THIS GLUCOSE LEVEL. IF FOLLOW-UP LAB WORK WAS DONE BEFORE OR AFTER THE IV GLUCOSE WAS ADMINISTERED. HOW MUCH GLUCOSE THE PATIENT WAS GIVEN AND WHETHER ANY OTHER MEDICATIONS WERE ADMINISTERED TO THE PATIENT WHILE IN THE HOSPITAL. IF THE PATIENT HAD ANY OTHER MEDICAL CONDITIONS AND WHAT, IF ANY, MEDICATIONS THE PATIENT WAS TAKING. MEDICAL HISTORY AGE, WEIGHT. SUSPECT METER WAS RECEIVED AND EVALUATED AT LIFESCAN IN 08/2005. ALL DISPLAY SEGMENTS WERE PRESENT NO PROBLEM WAS FOUND. NOTE THAT A DISPLAY OF "H1" WITH MISSING SEGMENTS WOULD HAVE APPREARED AS "11." (WITH THE "DECIMAL POINT" OCCURRING TO THE RIGHT OF BOTH 1'S AND LOWER THAN A DECIMAL POINT SHOULD HAVE BEEN), NOT AS "1.1". METER'S MEMORY REVEALED 6 INSTANCES OF "H1" IN 07/2005. THERE WAS NO EVIDENCE OF TESTING IN JULY, 2005, THE DAY ON WHICH THE RESULT OF "1.1" WAS ALLEGEDLY OBTAINED. THE TWO TESTS IN 07/2005 WERE RECORDED AS AN ERROR 3 AND ERROR 6, WHICH ARE GENERALLY USE ERROR. THE LAST TEST WAS A SINGLE RESULT OF 7.9 IN JULY.