Description of Event or Problem · 1
THE PT REPORTED OUT OF RANGE NORMAL CONTROL SOLUTION TEST RESULTS AND HIGHER BLOOD GLUCOSE READINGS WITH DEVICE, LOT 16136A. UPON INITIAL OPENING, THE PT PERFORMED A NORMAL CONTROL SOLUTION TEST AND OBTAINED A RESULT THAT WAS WITHIN THE NORMAL CONTROL SOLUTION RANGE (NO SPECIFIC RESULT AVAILABLE). HE DOES NOT KNOW THE LOT NUMBER OF THE CONTROL SOLUTION HE USED AT THIS TIME. THE PT FELT THAT HE WAS OBTAINING ACCURATE BLOOD GLUCOSE READINGS UNTIL ONE WEEK AGO WHEN HE OBTAINED THREE CONSECUTIVE BLOOD GLUCOSE READINGS (AT DIFFERENT TIMES, ON DIFFERENT DAYS) OF OVER 180 MG/DL. HIS TYPICAL BLOOD GLUCOSE READINGS THE PREVIOUS WEEK WITH DEVICE WERE IN THE 120 MG/DL RANGE. BECAUSE HE FELT THE 180 MG/DL READINGS WERE SIGNIFICANTLY HIGHER, HE PERFORMED TWO BACK TO BACK NORMAL CONTROL SOLUTION TESTS. HE OBTAINED TWO NORMAL CONTROL SOLUTIONS TEST RESULTS OF 181 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 111-167 MG/DL (SOLUTION LOT VE185, EXP 5/97). THE PT SHOOK THE CONTROL SOLUTION BEFORE HE APPLIED THE SAMPLE TO THE TEST PAD. THE CONTROL SOLUTION WAS OPENED APPROX ONE MONTH AGO. WITH THE REPRESENTATIVE, THE PT OBTAINED A NORMAL CONTROL SOLUTION RESULT OF 182 MG/DL. WHEN THE REPRESENTATIVE SPOKE WITH THE PT, NO DESICCANT WAS PRESENT IN THE DEVICE BOTTLE. THE PT STATED THAT HE DID NOT REMOVE THE DESICCANT FROM THE BOTTLE, BUT DOES NOT REMEMBER WHETHER DESICCANT WAS PRESENT IN THE BOTTLE UPON INITIAL OPENING. WITH THE REPRESENTATIVE, THE PT OBTAINED A CHECK STRIP RESULT OF 75 VERSUS A CHECK STRIP RANGE OF 68-92. THE PT STORES THE TEST STRIPS IN HIS BEDROOM.