ALBUMIN

Description of Event or Problem

THE CUSTOMER REPRESENTATIVE RECEIVED AN EMAIL STATING THE CUSTOMER RECEIVED QUESTIONABLE ALBUMIN (ALB) RESULTS ON THEIR MODULAR ANALYTICS P-MODULE, SERIAL NUMBER (B)(4). THE CUSTOMER NOTICED THE ERRONEOUS ALB RESULTS DUE TO THE TOTAL PROTEIN COMPARISON THEY USE ON ALL SAMPLES. THE CUSTOMER BELIEVED THEY MIGHT HAVE HAD A DEFECTIVE REAGENT CARTRIDGE. THE CUSTOMER STATED THERE WAS ALMOST A PLASTIC DIVIDER IN THE BOTTLE, FORMED WHERE THE BOTTLE SEAMS WERE, WHICH MAY HAVE CAUSED OR EXACERBATED FOAMING. THE CUSTOMER STATED THERE APPEARED TO BE A LOT OF BUBBLES ON THE TOP THAT RESULTED IN INCORRECT RESULTS BEING REPORTED. THE CUSTOMER REPLACED THE REAGENT CARTRIDGE, RECALIBRATED, AND RAN CONTROLS. THE CUSTOMER FELT EVERYTHING SHOULD BE BACK TO NORMAL AT THIS TIME. EIGHTEEN PATIENTS WERE FOUND TO HAVE BEEN INCORRECTLY REPORTED AND WERE CORRECTED. REPEAT TESTING WAS PERFORMED ON ANOTHER P-MODULE, SERIAL NUMBER (B)(4). PATIENT 1 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 2 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.3 G/DL. PATIENT 3 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 4 HAD AN INITIAL ALB RESULT OF 7.0 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 5 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 6 HAD AN INITIAL ALB RESULT OF 6.4 G/DL. THE REPEAT RESULT WAS 3.1 G/DL. PATIENT 7 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.5 G/DL. PATIENT 8 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.2 G/DL. PATIENT 9 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 10 HAD AN INITIAL ALB RESULT OF 6.7 G/DL. THE REPEAT RESULT WAS 3.9 G/DL. PATIENT 11 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.4 G/DL. PATIENT 12 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.7 G/DL. PATIENT 13 HAD AN INITIAL ALB RESULT OF 6.5 G/DL. THE REPEAT RESULT WAS 2.5 G/DL. PATIENT 14 HAD AN INITIAL ALB RESULT OF 4.1 G/DL. THE REPEAT RESULT WAS 2.0 G/DL. PATIENT 15 HAD AN INITIAL ALB RESULT OF 6.4 G/DL. THE REPEAT RESULT WAS 2.9 G/DL. PATIENT 16 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 3.5 G/DL. PATIENT 17 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 2.9 G/DL. PATIENT 18 HAD AN INITIAL ALB RESULT OF 6.6 G/DL. THE REPEAT RESULT WAS 4.2 G/DL. THERE WERE NO ADVERSE EVENTS. THE CUSTOMER DECLINED A SERVICE VISIT BELIEVING THE REAGENT BOTTLE WAS THE ISSUE.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED REAGENT FOR INVESTIGATION. AN INCREASE IN BUBBLES DUE TO THE PLASTIC DIVIDER WAS NOT OBSERVED. QUALITY CONTROL RECOVERY WAS WITHIN SPECIFICATION. A SPECIFIC ROOT CAUSE FOR THIS EVENT COULD NOT BE IDENTIFIED. NO ADVERSE EVENT WAS REPORTED.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.