D
Patient 1
THE CUSTOMER RECEIVED QUESTIONABLE HEMOGLOBIN A1C RESULTS FOR APPROXIMATELY 150 PATIENT SAMPLES AND QC MATERIAL. A PHYSICIAN CALLED AND QUESTIONED THE RESULTS. SAMPLES WERE EITHER REPEATED ON THE SAME ANALYZER OR ANOTHER INTEGRA 800 AT THE SITE. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE AS AN EXAMPLE. THE INITIAL RESULT WAS 7.3% AND THE REPEAT RESULTS ON (B)(6) 2013 WERE 5.4 % AND 5.3%. ALL OF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THERE WERE NO ADVERSE EVENTS. THE HEMOGLOBIN A1C REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE TECH OPERATING THE ANALYZER AT TIME OF THE EVENT STATED HE WAS ABLE TO CORRECT THE ISSUE, BUT SPECIFIC INFORMATION WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE NOTED IT WAS LIKELY THE ANALYZER EXPERIENCED A FULL OR PARTIAL PROBE CLOT DURING THE RUN AND WAS IN NEED OF REPLACEMENT. THE POST RUN QC RESULTS WERE NOT VALIDATED TO EXPOSE THE ERRORS AND SUBSEQUENTLY MAINTENANCE WAS PERFORMED AND MAY HAVE CORRECTED THE ISSUE WITHOUT KNOWLEDGE OF SAMPLES IN NEED OF CORRECTIVE ACTIONS. HE COMMUNICATED TO THE CUSTOMER THE ORDER OF EVENTS AND SUGGESTED ADDITIONAL INSTRUMENT HEALTH CHECKS, SUCH AS PROBE THROUGHPUT CHECKS, TO ENSURE ACCURATE RESULTS. HE SUCCESSFULLY VERIFIED THE ANALYZER WAS IN WORKING ORDER WITH PROPER CALIBRATION AND QC RESULTS.