FDA Adverse Event Malfunction Summary report: N

SYNCHRON LXI 725 SYSTEM

MDR report key: 2592831 · Received May 30, 2012

Report

Report Number: 2122870-2012-01412
Event Type: Malfunction
Date Received: May 30, 2012
Date of Event: May 11, 2012
Report Date: May 11, 2012
Manufacturer: BECKMAN COULTER, INC.
Product Code: JLB
PMA / PMN Number: K023049
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF THE INSTRUMENT'S EVENT LOG AND ARCHIVE DATA FILE INDICATED THE ERRONEOUS QUALITY CONTROL RESULTS WERE CONSISTENT WITH THE INSTRUMENT ASPIRATING THE SAMPLE FROM THE INCORRECT RACK POSITION. THE INSTRUMENT SOFTWARE RECOGNIZED A SAMPLE CAROUSEL MOTION ERROR OCCURRED AND RECOVERED, BUT NOT ALL AFFECTED RESULTS WERE FLAGGED. THIS ISSUE IS UNDER FURTHER INVESTIGATION BY BECKMAN COULTER INC. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A FALSE LOW QUALITY CONTROL (QC) RESULT FOR B-TYPE NATRIURETIC PEPTIDE (BNP) AND CREATINE KINASE-MB ISOENZYME (CK-MB), RESPECTIVELY WERE GENERATED FROM A SYNCHRON LXI 725 SYSTEM. THE CUSTOMER ALSO REPORTED RECEIVING A SYS-FLAGGED "NO VALUE" RESULT FOR A CARDIAC TROPONIN (ACCUTNI) LEVEL ONE QUALITY CONTROL RESULT AS WELL AS A LEVEL THREE CK-MB QC RESULT AFTER A "SAMPLE CAROUSEL MOTION ERROR" MESSAGE WAS POSTED TO THE INSTRUMENT EVENT LOG. REPEAT QC RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRON LXI 725 SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	JLB	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1