STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324120309) WERE USED FOR THE COMPLAINT INVESTIGATION. TESTING INCLUDED FIVE (5) LEVELS OF NOVA STATSTRIP GLUCOSE LINEARITY SOLUTION, AND FIVE (5) LEVELS OF WHOLE BLOOD SPECIMENS COLLECTED FROM CONSENTING ADULTS. FIVE (5) NOVA STATSTRIP GLUCOSE METERS AND ONE (1) RETURNED NOVA STATSTRIP GLUCOSE METER WERE USED FOR THE STUDY. FOUR (4) MEASUREMENTS WERE PERFORMED ON EACH METER FOR EACH SAMPLE (24 MEASUREMENTS TOTAL). PLASMA YSI GLUCOSE RESULTS WERE USED AS REFERENCE VALUES FOR THE WHOLE BLOOD SPECIMENS. RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324120309) MEET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SPECIMENS FOR TESTING DONE USING RETAINED NOVA STATSTRIP GLUCOSE METERS. THERE WERE NO DISCREPANT VALUES OBTAINED DURING THE TESTING OF RETAINED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324120309). AFTER INVESTIGATION INTO THE ONE VIAL OF RETURNED NOVA STATSTRIP GLUCOSE TEST STRIPS (LOT # 0324120309) SEEMED TO INDICATE THAT THE VIAL HAD BEEN EXPOSED TO MOISTURE, THEREBY GIVING THE ERRONEOUS RESULTS SEEN; INDICATING AN ISSUE WITH THAT PARTICULAR VIAL OF STRIPS BUT NOT WITH THE WHOLE STRIP LOT OR THE REPORTED METER. THE VIAL WEIGHT OF THE RETURNED VIAL WAS 17.1980G AND THE WEIGHT OF AN UNUSED RETAIN VIAL WAS 16.178G. THIS SUPPORTS THAT THEORY THAT THE RETURNED VIAL WAS EXPOSED TO MOISTURE AT SOME POINT. DHR REVIEWS WERE PERFORMED ON THE REPORTED METER AND STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR'S INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN RETURNED. THE INVESTIGATION IS ANTICIPATED BUT NOT YET BEGUN. NO REPORTED ADVERSE EFFECT TO THE NEONATE. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

"WHILE USING A GLUCOMETER ON PEDIATRIC PATIENTS, THREE CONSECUTIVE READINGS SHOWED RESULTS OF >600 MG/DL FROM DIFFERENT TWO PATIENTS. HOWEVER, THE GLUCOMETER PASSED QUALITY CONTROL (QC) CHECKS EARLIER THAT DAY. SUSPECTING AN ABNORMALITY, THE NURSE REPEATED THE TESTS USING A DIFFERENT VIAL OF TEST STRIPS, AND THE >600 READINGS DID NOT RECUR. HOWEVER, SINCE >600 REPORT HAD ALREADY BEEN REPORTED, BLOOD SAMPLES WAS WITHDRAWN AND SENT TO THE LABORATORY FOR CONFIRMATION, DATA WAS 55 MG/DL. THE NURSE THEN PROVIDED THE ORIGINAL VIAL OF TEST STRIPS TO THE LABORATORY, BUT WHEN TESTED QC USING THE LAB'S GLUCOMETER, THE RESULT COULD NOT PRODUCE AND SHOWED ERROR (BAD SAMPLE OR REPLACE STRIP). THE LABORATORY REPORTED THAT A FEW DAYS EARLIER, ANOTHER UNIT HAD ALSO ENCOUNTERED >600 READINGS DURING QC CHECKS WITH A DIFFERENT VIAL FROM THE SAME BATCH, AND HAD DISCARDED THAT VIAL. "