Description of Event or Problem · 1
THE CUSTONMER, AN INSULIN DEPENDENT DIABETIC, REPORTED INACCURATELY HIGH BLOOD GLUCOSE READINGS WITH TEST STRIPS, LOT 16200A. THE DAY PRIOR TO USING TEST STRIP, THE CUSTOMER HAD OBTAINED BLOOD GLUCOSE READINGS WITH A SECOND CO'S TEST STRIPS OF 168, 187, AND 219 MG/DL. ON 1/27/97, HE OPENED A NEW BOTTLE OF THE FIRST TEST STRIPS, LOT 16200A. ON THAT DAY HE OBTAINED BLOOD GLUCOSE READINGS OF 305, 204, 242, 176, AND 190 MG/DL. (THE CUSTOMER RECENTLY GOT AN INSULIN PUMP SO HE IS TESTING FREQUENTLY TO ADJUST INSULIN LEVELS CORRECTLY). ON 1/28/97, HE OPENED THE SECOND BOTTLE FROM THE SAME BOX AND OBTAINED RESULTS OF 198, 236, 251, 232, 218, AND 252 MG/DL. BECAUSE HE THOUGHT THE READINGS WERE HIGH, THE CUSTOMER PERFORMED A NORMAL CONTROL SOLUTION TEST WITH ANOTHER CO NORMAL CONTROL SOLUTION, LOT V1176, EXP 9/98. THE CONTROL SOLUTION HAS BEEN OPEN LESS THAN ONE MONTH AND THE CUSTOMER SHOOK IT BEFORE APPLYING THE SAMPLE. HE OBTAINED A RESULT OF 176 MG/DL VERSUS A NORMAL CONTROL RANGE OF 103-155 MG/DL. THE CUSTOMER THEN PERFORMED SOME COMPARISON TESTS. WITH THE FIRST TEST STRIPS HE OBTAINED A READING OF 218 MG/DL. AT THE SAME TIME HE OBTAINED A RESULT OF 148 MG/DL WITH THIRD DEVICE AND ANOTHER READING OF 148 MG/DL WITH A FOURTH DEVICE. LATER THAT SAME DAY HE OBTAINED A READING WITH THE FIRST DEVICE OF 252 VERSUS A RESULT WITH THE THIRD DEVICE OF 178 MG/DL. HE PERFORMED ADD'L COMPARISON TEST WITH THE FIRST DEVICE VERSUS THE THIRD DEVICE. THE RESULT USING A TEST STRIP FROM THE FIRST BOTTLE OF THE FIRST DEVICE WAS 295 MG/DL VERSUS 231 MG/DL WITH THE THIRD DEVICE. THE RESULT WITH A TEST STRIP FROM THE SECOND BOTTLE OF THE FIRST DEVICE WAS 264 VERSUS 2214 MG/DL WITH THE THIRD DEVICE. THE CUSTOMER STATED THAT ON ONE OCCASION BETWEEN 1/25/97 AND 1/29/97, HE TOOK TOO MUCH INSULIN BECAUSE HIS READING WITH THE FIRST DEVICE WAS INACCURATELY HIGH. AS A RESULT, HIS BLOOD SUGAR BECAME EXTREMELY LOW AND HE HAD TO DRINK JUICE. THE CUSTOMER SAID THAT HE REMOVED THE DESICCANT FROM THE FIRST BOTTLE OF THE FIRST DEVICE 1 OR 2 DAYS AFTER OPENING THE BOTTLE AND THREW IT AWAY. THE DESICCANT IS IN THE SECOND BOTTLE. THE CODE WAS SET CORRECTLY FOR ALL TESTS. THE CUSTOMER STORES THE TEST STRIPS IN THE KITCHEN. THE CUSTOMER PUT THE LAST 3 TEST STRIPS FROM BOTTLE # 1 INTO BOTTLE #2.