PANTHER SYSTEM

Additional Manufacturer Narrative

THIS IS THE FINAL REPORT: DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE BARCODE SCANNER RETURNED FROM JRC HAD BOTH CODABAR 4-25 AS WELL AS CODABAR 11 PROGRAMMED INTO THE BARCODE SYMBOLOGY SETTINGS. FIELD SERVICE BULLETIN FS-325, USED BY GRIFOLS FSE TO INSTALL, INSTRUCTS THE FSE TO PROGRAM CODABAR 11 BUT DOES NOT EXPLICITLY STATE THAT THE CODABAR 4-25 NEEDS TO BE REMOVED OR NOT PROGRAMMED AT ALL. FURTHER INVESTIGATION FROM SUPPLIER REVEALED A CODING BUG IN THE SOFTWARE THAT BARCODES CAN CONCATENATE AND PRODUCE LONGER THAN EXPECTED AND INCORRECT BARCODES; PARTICULARLY SINCE THE BARCODE HAD BOTH CODABAR11 AND CODABAR 4-25. IF ONLY ONE SYMBOLOGY WAS INSTALLED, THEN THE MISREAD WOULD NOT HAVE OCCURRED. AS A CORRECTIVE ACTION, FS-325 BULLETIN WILL BE REVISED TO EXPLICITLY STATE ONE BARCODE SYMBOLOGY BEING PROGRAMMED INTO THE SCANNER. AS FURTHER MITIGATION INTO THIS ISSUE, HOLOGIC WILL FIX IN THE NEXT REVISION OF SOFTWARE VERSION 7.0. THIS SOFTWARE WILL NOT BE AVAILABLE UNTIL END OF 2018 OR EARLY 2019, BASED ON THE CURRENT DEVELOPMENT SCHEDULE.

Description of Event or Problem

GRIFOLS' CUSTOMER, THE (B)(6) REPORTED DURING AN ULTRIO ELITE ASSAY RUN, THAT SAMPLE ID (B)(6) WAS MISREAD AS (B)(6) BY THE PANTHER INSTRUMENT. CUSTOMER IDENTIFIED THIS ISSUE WHEN THE LABORATORY INFORMATION SYSTEM (LIS) DID NOT HAVE A RESULT FOR THE SAMPLE ID (B)(6). AT THAT TIME, THEY DISCOVERED THE PANTHER INSTRUMENT MISREAD AS (B)(6). THE NUMBER CREATED BY THE PANTHER DID NOT EXIST IN SITE AS A DONOR SYSTEM RECORD. NO INCORRECT RESULT WAS REPORTED OUT. HOLOGIC SW TEAM CONFIRMED THE ISSUE WAS NOT SOFTWARE RELATED BUT A POSSIBLE FIRMWARE ISSUE. PANTHER SUPPLIER WAS NOTIFIED AND FURTHER INVESTIGATION IS ONGOING.