Description of Event or Problem · 0
ON (B)(6) 2022, DATA INNOVATIONS LLC RECEIVED A REPORT THAT AFTER A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE AT A USER FACILITY, RESULTS WERE THEN REPORTED OUT FROM THE LIS THAT DID NOT CONTAIN THE GREATER THAN OR LESS THAN CHARACTERS. A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ROCHE DIAGNOSTICS (DISTRIBUTOR), AND MEDICAL HEALTH SERVICES (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT ON (B)(6) 2022, THE FACILITY HAD A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE BY ORCHARD THAT INCLUDED A CLOUD SERVER MIGRATION AND SINCE THAT TIME, RESULTS FOR VITAMIN D, VITAMIN B12, FOLATE, DHEA (DEHYDROEPIANDROSTERONE), AND TESTOSTERONE WERE BEING REPORTED OUT WITHOUT GREATER THAN OR LESS THAN CHARACTERS IN THE RESULTS. AS AN EXAMPLE, VITAMIN D REPORTED AS "VITAMIN D - 100.0" SHOULD HAVE BEEN "VITAMIN D > 100.0" AND VITAMIN B12 REPORTED AS "VITAMIN B12 - 2000" SHOULD HAVE BEEN "VITAMIN B12 > 2000". INVESTIGATION BY THE DISTRIBUTOR DETERMINED THAT THERE WERE NO CHANGES WITHIN INSTRUMENT MANAGER (IM) AS A RESULT OF THE LIS UPGRADE. ADDITIONALLY, THERE WERE NO RULES (USER PROGRAMMED FACILITY LOGIC) IN INSTRUMENT MANAGER USED TO PERFORM THE CONVERSION OF THE RESULTS, RATHER THE LIS CONTROLS THE CONVERSION OF THE RESULTS AND THE REPORTING OF RESULTS. THE ORCHARD LIS IS NOT OWNED BY DATA INNOVATIONS OR RELATED TO THE INSTRUMENT MANAGER SOFTWARE. AT THE LIS VENDOR'S RECOMMENDATION, THE FACILITY HAS SINCE CREATED RULES WITHIN THE LIST TO ENSURE GREATER THAN AND LESS THAN CHARACTERS ARE ALWAYS REPORTED OUT IN ORDER TO PREVENT RECURRENCE OF THE ISSUE. INVESTIGATION BY THE FACILITY DETERMINED THAT 57 PATIENTS HAD INCORRECT RESULTS REPORTED OUT WITHOUT A GREATER THAN SIGN. IT IS NOT KNOWN HOW THE DISCREPANT RESULTS MAY OR MAY NOT HAVE AFFECTED PATIENT TREATMENT AS THE FACILITY DOES NOT HAVE DIRECT CONTACT WITH TREATING PROVIDERS. THE FACILITY IS NOT AWARE OF ANY ADVERSE IMPACT TO PATIENTS AT THIS TIME. FDA SAFETY REPORT ID #(B)(4).