FDA Adverse Event Injury Summary report: N

UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

MDR report key: 1964405 · Received January 19, 2011

Report

Report Number: 2122870-2011-00068
Event Type: Injury
Date Received: January 19, 2011
Date of Event: December 21, 2010
Report Date: December 21, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: MMI
PMA / PMN Number: K060256
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SAMPLES WERE SERA THAT WERE CENTRIFUGED FOR 10 MINUTES AT 3000 G. THE SAMPLES WERE ASPIRATED FROM THE PRIMARY TUBES FOR ANALYSIS. DURING THE TROUBLESHOOTING THE CUSTOMER STATED TO BCI FIELD SERVICE ENGINEER THAT THE SAMPLE IN QUESTION CONTAINED FIBRIN STRANDS. SYSTEM CHECK ON THE INSTRUMENT WAS ACCEPTABLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE PRESENCE OF FIBRIN IN THE ORIGINAL SAMPLE IS THE LIKELY ROOT CAUSE FOR THIS EVENT. ASSISTED TROUBLESHOOTING.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY A PHYSICIAN AFTER A SUBSEQUENT SAMPLE RESULTED IN THE NORMAL REFERENCE RANGE. REPEAT TESTING ON THE ORIGINAL SAMPLE PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	MMI	BECKMAN COULTER, INC.	DXC 600I	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other