Description of Event or Problem · 1
THE CUSTOMER REPORTED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS. THE CUSTOMER STATED THAT HE OPENED THE FIRST BOTTLE FROM A BOX OF FIFTY AND PERFORMED A NORMAL CONTROL SOLUTON TEST. THE RESULT WAS 151 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 110-166 MG/DL. HE THEN PERFORMED A BLOOD GLUCOSE TEST AND OBTAINED A RESULT OF 63 MG/DL. HE THOUGHT THIS READING WAS INACCURATE BECAUSE HE DID NOT HAVE HYPOGLYCEMIC SYMPTOMS. THE CUSTOMER OPENED THE FIRST BOTTLE FROM A NEW BOX OF SECOND TEST STRIPS AND PERFORMED A BLOOD GLUCOSE TEST. THE RESULT WAS 257 MG/DL. THE CUSTOMER CALLED THE CO CUSTOMER SUPPORT LINE AND, WITH THE REP PERFORMED A NORMAL CONTROL SOLUTION TEST WITH THE FIRST TEST STRIP. THE RESULT WAS 151 MG/DL. THE RESULT OF A NORMAL CONTROL SOLUTION TEST WITH A SECOND TEST STRIPS WAS 94 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 80-113 MG/DL. ALSO WITH THE REP, THE CUSTOMER PERFORMED A BLOOD GLUCOSE TEST WITH A SECOND TEST STRIP, (LOT #643243A, CODE 8, EXPIRATION 10/98) AND OBTAINED A READING OF 221 MG/DL. HE IMMEDIATELY PERFORMED A BLOOD GLUCOSE TEST WITH FIRST TEST STRIP AND OBTAINED A RESULT WAS 42 MG/DL. THE CONTROL SOLUTION, NORMAL CONTROL SOLUTION, LOT #V1225, EXPIRATION 8/97, WAS OPENED TODAY AND WAS SHAKEN VIGOROUSLY BEFORE THE SAMPLE WAS APPLIED. THE CUSTOMER PERFORMED A CHECK STRIP TEST WITH THE REP AND OBTAINED A RESULT OF 84 VERSUS A CHECK STRIP RANGE OF 70-96. THE DESICCANT IS IN THE OPEN BOTTLE. THE CUSTOMER STORES THE TEST STRIPS IN THE BEDROOM.