FDA Adverse Event Malfunction Summary report: N

ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

MDR report key: 1904004 · Received November 20, 2010

Report

Report Number: 2122870-2010-00787
Event Type: Malfunction
Date Received: November 20, 2010
Date of Event: October 18, 2010
Report Date: October 21, 2010
Manufacturer: BECKMAN COULTER INC.
Product Code: DHA
PMA / PMN Number: K023049
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE BHCG SAMPLES ARE COLLECTED IN 13X100MM GOLD TOPPED SERUM TUBES WITH A GEL SEPARATOR. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE SAMPLES WERE ANALYZED THROUGH THE CLOSE TUBE ACCESSION (CTA). PER CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AT 01:22 WHICH PASSED WELL WITHIN INSTRUMENT SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG DURING THE TIMEFRAME IN WHICH THE ERRONEOUS RESULT WAS OBTAINED. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED A DILTEST WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE DID NOT NOTE ANY HARDWARE ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS FALSE BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WITHIN THE NORMAL REFERENCE RANGE FOR ONE PATIENT'S GENERATED BY ACCESS 2I (LXI) IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE ORIGINAL SAMPLE AND A NEW SAMPLE WERE TESTED AND PRODUCED HIGH RESULTS WITHIN A DIFFERENT GESTATIONAL CATEGORY, WHICH BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS 2I (LXI) IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER,	DHA	BECKMAN COULTER INC.	ACCESS 2I (LXI)	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1