FDA Adverse Event Malfunction Summary report: N

UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

MDR report key: 2600053 · Received June 6, 2012

Report

Report Number: 2122870-2012-01440
Event Type: Malfunction
Date Received: June 6, 2012
Date of Event: May 11, 2012
Report Date: May 11, 2012
Manufacturer: BECKMAN COULTER, INC.
Product Code: DHA
PMA / PMN Number: K023764
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON THREE DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2012-01438, 2122870-2012-01439.

Description of Event or Problem · 1

CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (DXI 800) GENERATED NON-REPRODUCIBLE BHCG (BETA HUMAN CHORIONIC GONADOTROPIN) PATIENT RESULTS ON THREE DAYS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT ACCESS TBHCG2 REAGENT, LOT 120574, AND ACCESS TBHCG2 CALIBRATORS (S0-S5), LOT 022920, WERE USED IN CONJUNCTION WITH THE DXI 800 ANALYZER. BEC FIELD SERVICE ENGINEER (FSE) DID NOT FIND ANY MALFUNCTION IN INSTRUMENT HARDWARE HAD OCCURRED. THE FSE CLEANED AND REBUILT THE WASH AND PRECISION VALVES AND CLEANED UNDER THE REAGENT PIPETTOR STATION PLATES. THE FSE THEN PERFORMED THE NECESSARY ALIGNMENTS AND MADE ADJUSTMENTS TO THE LUMINOMETER. THE FSE ASSISTED WITH ASSAY CALIBRATION AND QUALITY CONTROL; ALL RESULTS WERE WITHIN SPECIFICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	DHA	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1