Description of Event or Problem · 0
PATIENT PRESENTED ON (B)(6) 2024 0706 TO OUTPATIENT DRAW SITE. SAMPLE SENT TO (B)(6) HOSPITAL CORE LABORATORY. SODIUM RESULT 125MMOL/L (FLAGGED ABNORMAL LOW )- PATIENT WAS INSTRUCTED BY ORDERING PHYSICIAN TO GO TO EMERGENCY ROOM FOR FOLLOW UP. SAMPLE COLLECTED IN EMERGENCY ROOM ON (B)(6) 2024 1338. SODIUM RESULT = 136MMOL/L (NORMAL). PATIENT SUBMITTED COMPLAINT TO OUTPATIENT DRAW SITE ON (B)(6) 2024 FOR DISCREPANT SODIUM RESULTS. (B)(6) HOSPITAL CORE LABORATORY RETESTED THE ORIGINAL SAMPLE FROM THE OUTPATIENT DRAW SITE. SODIUM = 138MMOL/L (NORMAL). NO INTERNAL ISSUES IDENTIFIED WITH SODIUM TEST PERFORMANCE. LABORATORY OPENED CASE WITH VENDOR, QUIDELORTHO. QUIDEL ORTHO RESPONDED AS FOLLOWS: DEEP CLEAN OF THE ANALYZER IS NECESSARY BECAUSE CURRENT LOT NUMBER (GEN20) OF ALBUMIN / TP UNDER INVESTIGATION DUE TO MULTIPLE CUSTOMER COMPLAINTS OF RANDOM LOW SODIUM VALUES. QUIDEL ORTHO IS STILL INVESTIGATING THE MATTER BUT RIGHT NOW THEY HAVE REASON TO SUSPECT THAT THE ADHESION USED ON THAT GEN20 OF ALBUMIN / TP IS CREATING EXCESSIVE DUST. THE DUST COULD BE ACCUMULATING NEAR THE TIP LOCATOR WHICH IS ALSO THE AREA WHERE THE ERF AND SAMPLE FLUIDS ARE INTRODUCED TO THE SLIDE. THIS DUST COULD BE IMPACTING PERFORMANCE OF THE SODIUM ASSAY. NO PRODUCT NOTIFICATION HAS BEEN ISSUED BY QUIDEL ORTHO AS OF THIS REPORT. MEMORIAL REGIONAL LAB HAS COMPLETED DEEP CLEANING OF THE ANALYZER AND REMOVED AFFECTED LOTS FROM USE. NO FURTHER ISSUES IDENTIFIED.