(B)(4). DEVICE EVALUATION BY MANUFACTURER: ON 14-AUG-2017 A FIELD SERVICE ENGINEER (FSE) INSPECTED THE AIA-2000 ANALYZER FOR LEAKS OR ABNORMALITIES AND NONE WERE FOUND. THE FSE ALSO RAN DAILY CHECK. THE FSE COULD NOT DUPLICATE THE REPORTED THE REPORTED EVENT. THE AIA-2000 WAS PERFORMING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOUND NO OTHER SIMILAR COMPLAINTS DURING THIS TIME PERIOD. THE ROOT CAUSE OF THE REPORTED DISCREPANT T4 PATIENT RESULT COULD NOT BE DETERMINED.
D
Patient 1
ON (B)(6) 2017 A CUSTOMER REPORTED A T4 (THYROXINE) PATIENT RESULT OF 1.93 UG/DL AND UPON REPEAT IT WAS 1.42 UG/DL (NORMAL RANGE 0.5 - 24 UG/DL). THE CUSTOMER REPORTED THAT BIO-RAD QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGE. THE CUSTOMER REPORTED THAT THE SAMPLE WAS CLOTTED FOR 30 TO 60 MINUTES AND SPUN FOR 10 MINUTES. THE CUSTOMER RUNS SAMPLES AND QC IN INSERT CUPS INSIDE THE ORIGINAL BARCODED TUBES. SOME SAMPLES ARE FROZEN, BUT THE CUSTOMER DID NOT KNOW IF THE SAMPLE IN QUESTION WAS. THE CUSTOMER STATED THAT THE SAMPLE IN QUESTION WAS NOT REPORTED OUT OF THE LABORATORY. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
N
Patient 1
(B)(4). REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".