PANTHER SYSTEM
Received Mar 11, 2017 · Event occurred Feb 10, 2017
Report 2024800-2017-00011 · MDR key 6397708
Device
Product problems
- Data Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER AT DYNALIFE DIAGNOSTICS REPORTED ON (B)(6) 2017 THAT THE PATIENT'S SAMPLE ID DID NOT MATCH WHAT WAS ON THE RUN REPORT. THE SAMPLE WAS RUN ON (B)(6) 2017 AND SAMPLE ID ON THE RUN REPORT WAS (B)(4) BUT SHOULD HAVE BEEN (B)(4) THE SAMPLE WAS NEG FOR BOTH CT AND GC. CUSTOMER RETESTED THE SAMPLE ON (B)(6) 2017 FOR CT ONLY, AS THE PHYSICIAN ONLY REQUESTED CT ONLY RESULT. THE RESULT WAS NEGATIVE AND INDICATED THE CORRECT SAMPLE ID (B)(4). THE NEG CT RESULT HAS BEEN REPORTED TO THE PHYSICIAN. FSE SENT THE COMPUTER AND A PICTURE OF THE BARCODE SAMPLES TO HOLOGIC FOR INVESTIGATION. REVIEW OF CUSTOMER RUN SHOWS THERE WERE NO ISSUES WITH THE SCANNER FIRMWARE OR LOGS. INVESTIGATION SHOWED THAT THE PANTHER SOFTWARE WAS FUNCTIONING AS INTENDED. HOLOGIC REQUESTED THE BARCODES FOR FURTHER INVESTIGATION BUT THEY WERE NOT PROVIDED.