Description of Event or Problem · 1
CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS. SHE OPENED THE BOTTLE ON 8/15/96 AND NOTICED THAT HER READINGS WERE SLIGHTLY LOWER THAN USUAL READINGS WITH CO TEST STRIPS. SHE OBTAINED READINGS IN THE 70-90 MG/DL RANGE WITH THE TEST STRIPS. HER USUAL READINGS WITH OTHER TEST STRIPS ARE IN THE 110-170 MG/DL RANGE. APPROX ONE WEEK LATER, HER READINGS FELL TO THE 30-50 MG/DL RANGE. SHE THOUGHT THESE READINGS WERE INACCURATE BECAUSE SHE DID NOT HAVE HYPOGLYCEMIC SYMPTOMS. SHE PURCHASED SOME TEST STRIPS AND PERFORMED A SIDE BY SIDE COMPARISON. THE RESULT WITH ANOTHER TEST STRIP WAS 270 MG/DL AND THE RESULT WITH CO'S DEVICE WAS 39 MG/DL. THE CUSTOMER STATED THAT SHE PERFORMED A NORMAL SOLUTION RANGE OF 105-157 MG/DL. AT THAT TIME, SHE ALSO PERFORMED A CHECK STRIP TEST AND THE RESULT WAS IN RANGE (NO SPECIFIC RESULT AVAILABLE). THE CODE WAS SET CORRECTLY FOR ALL TESTS. BECAUSE THE CUSTOMER USED ALL OF THE TEST STRIPS ATTEMPTING TO GET AN ACCURATE READING, NO TEST STRIPS WILL BE RETURNED FOR EVALUATION. THE DSI REP REQUESTED THAT THE CUSTOMER RETURN THE BOTTLE WITH DESICCANT FOR EVALUATION.