FROM (B)(6) 2012, THE CUSTOMER RECEIVED QUESTIONABLE GENTAMICIN RESULTS FOR 18 SAMPLES FROM ADULTS AND BABIES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR FIVE PATIENT SAMPLES WERE DISCREPANT. PATIENT SAMPLE (B)(6) RESULTS WERE 3.94, 2.92, 3.40 AND 2.99 MG/L. ON (B)(6) 2012, PATIENT SAMPLE (B)(6) RESULTS WERE 2.43, 1.02, 1.94 AND 1.11 MG/L. ON (B)(6) 2012, THE RESULTS WERE 0.64 AND 0.64 MG/L. ON (B)(6) 2012, PATIENT SAMPLE (B)(6) RESULTS WERE 1.75, 0.49, 0.23, 2.53, 0.57, 0.26, 0.19 AND 0.20 MG/L. ON (B)(6) 2012, PATIENT SAMPLE (B)(6) RESULTS WERE 1.98, 0.80, 0.79, 0.76 AND 0.74 MG/L. ON (B)(6) 2012, PATIENT SAMPLE (B)(6) RESULTS WERE 1.56, 1.09, 2.50, 0.86 MG/L. IN SOME CASES, THE WRONG RESULT WAS REPORTED, IN OTHER CASES THE CORRECT RESULT WAS REPORTED. NO INFORMATION WAS PROVIDED TO DETERMINE WHICH RESULTS WERE REPORTED. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE GENTAMICIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.
N
Patient 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).
N
Patient 1
ON (B)(6) 2013, ADDITIONAL RESULTS WERE PROVIDED FOR SIX PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR TWO SAMPLES WERE DISCREPANT. ON (B)(6) 2012, PATIENT SAMPLE 1 RESULTS WERE 4.28, 2.76, 2.67, 3.68, 2.85 AND 2.52 MG/L. THE RESULT OF 2.52 MG/L WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, PATIENT SAMPLE 2 RESULTS WERE 1.91, 0.52, 0.58 AND 0.43 MG/L. THE RESULTS OF 0.58 AND 0.43 MG/L WERE REPORTED OUTSIDE THE LABORATORY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENTS WERE ADVERSELY AFFECTED.
N
Patient 1
THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE FIELD SERVICE REPRESENTATIVE PERFORMED MULTIPLE ACTIONS. THE ISSUE WAS PROBABLY CAUSED BY A WORN OUT O-RING AND/OR MOTOR OF THE FP PHOTOMETER POLARIZATION FILTER. THE FIELD SERVICE REPRESENTATIVE REPLACED THESE PARTS AS WELL AS THE LAMP LED OF THE FP PHOTOMETER AND THEN PERFORMED A NEW FP CALIBRATION. NO ADVERSE EVENT WAS REPORTED.