Description of Event or Problem · 1
THE PT REPORTED OUT OF THE RANGE NORMAL CONTROL SOLUTION TEST RESULTS WITH TEST STRIPS, LOT UNKNOWN. ON AN UNKNOWN DATE SOME TIME THIS MONTH, THE PT OPENED THE FIRST BOTTLE OF TEST STRIPS FROM THE BOX AND PERFORMED A NORMAL CONTROL SOLUTION TEST. SHE OBTAINED AN OUT OF RANGE CONTROL SOLUTION TEST RESULT (ON THE HIGH END OF THE RANGE, BUT SHE CANNOT REMEMBER THE SPECIFIC TEST RESULT). THE NORMAL CONTROL SOLUTION RANGE OF THE TEST STRIPS WAS 111-167 MG/DL. THE PT STATED THAT, BECAUSE OF THE OUT OF RANGE RESULT, SHE DISCARDED BOTH BOTTLES OF TEST STRIPS. THE CONTROL SOLUTION USED WAS "WITHIN EXPIRATION DATES" (BOTH USE LIFE AND SHELF LIFE EXPIRATION DATES). THE PT SHOOK THE CONTROL SOLUTION BEFORE SHE APPLIED THE SAMPLE. WITH THE REP, THE PT OBTAINED A CHECK STRIP TEST RESULT OF 92 VERSUS A CHECK STRIP RANGE OF 77-103. THE PT STORES THE TEST STRIPS IN HER BEDROOM. THE PT CANNOT RETURN THE TEST STRIPS TO CO BECAUSE THEY WERE DISCARDED.