VARIANTNBS WITH GDM 3.1 SOFTWARE
Received Oct 15, 2013 · Event occurred Sep 13, 2013
Report 2915274-2013-00010 · MDR key 3458984
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
ON (B)(6) 2013, A CUSTOMER LOCATED IN (B)(6) WAS USING THE VARIANT NBS SICKLE CELL PROGRAM AND NOTICED THAT A SAMPLE ((B)(6)) APPEARED TWICE ON THE SUMMARY REPORT. WITHIN THE SAME RUN, A SAMPLE RESULT ((B)(6)) SHOWED A FLAT LINE WITH NO PEAKS ON THE CHROMATOGRAM. ON (B)(6) 2013, THE OPERATOR REPEATED THE ENTIRE RUN TO FURTHER INVESTIGATE THE RESULTS THAT APPEARED TWICE ON THE SUMMARY REPORT AS WELL AS THE FLAT LINE CHROMATOGRAM. THE SUMMARY REPORT FROM THE SECOND RUN CONTAINED NO REPEATED SAMPLES AND ALL CHROMATOGRAMS SHOWED PEAKS (NO FLAT LINES). THE INCIDENT WAS REPORTED TO BIO-RAD LABS.
Additional Manufacturer Narrative
FOR PRELIMINARY INVESTIGATION BIO-RAD OBTAINED: BACK UP FROM THE INVESTIGATION'S DATABASE, PUNCH FILE, SUMMARY AND CHORMATOGRAMS OF INITIAL RUN AND REPEAT RUN.