FDA Adverse Event Malfunction Summary report: N

ACCESS® 2 IMMUNOASSAY SYSTEM

MDR report key: 1903888 · Received November 20, 2010

Report

Report Number: 2122870-2010-00770
Event Type: Malfunction
Date Received: November 20, 2010
Date of Event: September 26, 2010
Report Date: November 19, 2010
Manufacturer: BECKMAN COULTER INC.
Product Code: JJE
PMA / PMN Number: K922823/A007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ALL THREE LEVELS OF ESTRADIOL QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE LAST 30 DAYS. HOWEVER, ON (B)(6) 2010, STARTING AT APPROXIMATELY 12:30, ESTRADIOL QC BEGAN TO FAIL DUE TO ERRATIC RESULTS. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE VERIFIED THE LUMINOMETER AND ULTRASONICS PERFORMANCE; NO ISSUES WERE NOTED. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), REGARDING A HIGHER THAN EXPECTED ESTRADIOL RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE CLINICIAN. SUBSEQUENT TESTING PRODUCED LOWER RESULTS IN A DIFFERENT CLINICAL CATEGORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS® 2 IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	JJE	BECKMAN COULTER INC.	ACCESS® 2 IMMUNOASSAY SYSTEM

Patients

Seq	Age	Sex	Outcome	Treatment
1