GENIUS DIGITAL DIAGNOSITC SYSTEM

Additional Manufacturer Narrative

THE GENIUS DIGITAL DIAGNOSTICS INSTRUMENT SERIAL NUMBER (B)(6) WAS NOT RETURNED FOR EVALUATION AND REMAINED IN THE CUSTOMER SITE. TROUBLESHOOTING, REVIEW OF THE INSTRUMENT LOG, AND SIMILAR COMPLAINT REVIEW WERE PERFORMED. NINE ADDITIONAL COMPLAINTS FOR (B)(6) WERE REVIEWED AND NO OTHER COMPLAINTS FOR SIMILAR ISSUES WERE FOUND. THROUGH TROUBLESHOOTING AND LOG REVIEW CONFIRMED THE CUSTOMER ISSUE AND DETERMINED THAT THE EVENT RESULTED FROM OPERATOR RECOVERY ACTIONS FOLLOWING THE ERROR CONDITION. DURING OPERATOR-ASSISTED RECOVERY, THE MACHINE PROMPTED THE USER TO REMOVE A SLIDE FROM THE IMAGING STAGE AND WAS NOT FOLLOWED. AS PROCESSING RESUMED, ONE SLIDE REMAINED ON THE IMAGING STAGE WHILE ANOTHER SLIDE WAS LOADED ON TOP OF IT, RESULTING IN IMPROPER POSITIONING. THE SLIDE REMAINING ON THE IMAGING STAGE WAS IMAGED, WHILE THE SYSTEM ASSOCIATED THE RESULTING IMAGE WITH A DIFFERENT SLIDE ID, LEADING TO A MISMATCH BETWEEN THE STORED IMAGE AND THE PHYSICAL SLIDE ACCESSION. THE INVESTIGATION CONCLUDED THE EVENT WAS CONSISTENT WITH USE ERROR DURING RECOVERY AND IS ADDRESSED BY EXISTING DEVICE RISK CONTROLS AND LABELING.

Description of Event or Problem

THE CUSTOMER REPORTED A SLIDE MIX MATCH ON THE DIGITAL DIAGNOSTICS SYSTEM. HOLOGIC TROUBLESHOOTING BETWEEN CYTOTECHNOLOGISTS AND FIELD SERVICE ENGINEER CONFIRMED THAT THE IMAGE WAS ASSOCIATED WITH AN INCORRECT SLIDE ACCESSION ID. INCORRECT ACCESSION ID PRESENTS A RISK OF PATIENT SAMPLE MISIDENTIFICATION AND POTENTIAL MISDIAGNOSIS.