NOVA BIOMEDICAL GLUCOSE METER

Description of Event or Problem

SOURCE: (B)(6). 16 NOVA GLUCOSE METERS WERE RECENTLY RECEIVED AT (B)(6) AND HOSPITAL. THE CURRENT FIRMWARE (1.3) HAS A BARCODE SCANNING ISSUE: IF THE SCAN IS NOT ACCEPTED, THERE IS NO ALERT BUT INSTEAD THE METER WILL REVERT TO THE LAST ACCEPTED SCAN. QUALITY CONTROL HAS BEEN AFFECTED BECAUSE OF THIS ISSUE (LEVEL 3 SCANNED AND LEVEL 3 SOLUTION ADDED, METER DIDN'T ACCEPT SCAN SO REVERTED BACK TO LEVEL 1, AND QC FAILED BECAUSE RECORDED VALUE WAS NOT IN THE ACCEPTABLE RANGE FOR LEVEL 1). THERE IS A CONCERN THAT PATIENT TESTING COULD BE INCORRECTLY DOCUMENTED IF THE PATIENT SCAN IS NOT ACCEPTED AND THE METER REVERTS TO THE LAST ACCEPTED SCAN (A DIFFERENT PATIENT). NOVA COMPANY PLANS TO COORDINATE FIRMWARE UPDATE (TO 1.5) WITH (B)(6) HOSPITAL LABORATORY. REPORTER JOB TITLE: PATIENT SAFETY AND REGULATORY LEAD. ADDITIONAL PRODUCT DETAILS: FIRMWARE 1.3.14.13.