UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

Description of Event or Problem

CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY HAD DECREASED PARATHYROID HORMONE (PTH) QUALITY CONTROL RECOVERY ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (DXI 600 ANALYZER) WITH SERIAL NUMBER (B)(4). BEC CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOT THE ISSUE WITH THE CUSTOMER VIA THE TELEPHONE. CTS DETERMINED THAT THE REAGENT PACK WAS REMOVED FROM THE LABORATORY'S OTHER ANALYZER (SERIAL NUMBER (B)(4)) AFTER BEING USED FOR INTRAOPERATIVE INTACT PARATHYROID HORMONE AND THEN PLACED ON THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THEY USED PTH REAGENT PACK, LOT 122078, ON THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THE PTH REAGENT LOT 122078 WAS CALIBRATED USING PTH CALIBRATOR LOT 289723. CUSTOMER INDICATED THAT THEY WERE USING BIORAD QUALITY CONTROL MATERIAL, LOT 41650, LEVELS 1, 2, AND 3 AS QUALITY CONTROL. CUSTOMER REPORTED THAT 9 PATIENT SAMPLES WERE ANALYZED USING REAGENT PACK LOT 122078. CUSTOMER REPORTED THAT THE RESULTS WERE RELEASED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THEY WERE UNABLE TO REPEAT THE SAMPLES BECAUSE THE SAMPLES WERE STORED BEYOND THE ACCEPTABLE TIME TO PERFORM THE PTH ASSAY. CUSTOMER DID NOT PROVIDE ANY PATIENT DATA. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CTS ADVISED THE CUSTOMER TO REMOVE AND DISCARD PTH REAGENT PACK LOT 122078 AND LOAD A NEW REAGENT PACK USING PROPER TECHNIQUE. BEC ALSO ANALYZED THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)) EVENT LOG. THE EVENT LOG INDICATED THAT THE DXI 600 ANALYZER DISPLAYED TWO (2) "REAGENT PACK MONITORING ERRORS."

Additional Manufacturer Narrative

(B)(4).