FDA Adverse Event Malfunction Summary report: N

ACCESS® 2 IMMUNOASSAY SYSTEM

MDR report key: 2111946 · Received June 2, 2011

Report

Report Number: 2122870-2011-01689
Event Type: Malfunction
Date Received: June 2, 2011
Date of Event: April 28, 2011
Report Date: May 4, 2011
Manufacturer: BECKMAN COULTER INC.
Product Code: JJE
PMA / PMN Number: K922823/A007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT SAMPLES WERE PERFORMED UTILIZING CALIBRATOR REQUIRING FREEZER STORAGE; HOWEVER, THE CALIBRATOR STORAGE INFORMATION WAS NOT PROVIDED. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 WAS WITHIN ESTABLISHED SPECIFICATIONS. CALIBRATION DATED (B)(6) 2011 PASSED. QC WAS WITHIN ESTABLISHED RANGES. SERVICE INFORMATION WAS NOT SUPPLIED. A DEFINITIVE ROOT CAUSE IS UNKNOWN. ADDITIONAL MDRS FILED FOR THIS EVENT TO ADDRESS EACH DATE THAT THE RESULTS IN QUESTION WERE GENERATED: 2122870-2011-01684, 2122870-2011-01686, 2122870-2011-01687, 2122870-2011-01688, 2122870-2011-01690, 2122870-2011-01691.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI), REPORTING THAT THEY BELIEVE RESULTS FOR FREE T4 (FT4) ASSAY PERFORMED ON ACCESS 2 IMMUNOASSAY SYSTEM RECOVERED GREATER THAN THE BCI REFERENCE RANGE FOR MULTIPLE PATIENT SAMPLES TESTED BETWEEN (B)(6) 2011 THROUGH (B)(6) 2011. SPECIFIC DATES AND TIME OF EACH SAMPLE WERE NOT PROVIDED, ONLY RANGE OF DATES. PATIENT RESULTS ARE PROVIDED. THESE RESULTS CORRESPOND TO TSH RESULTS WITHIN BCI'S NORMAL REFERENCE RANGE. THE FT4 RESULTS WERE REPORTED OUT OF THE LAB. THERE WERE NO REPORTS REGARDING AN EFFECT TO A PATIENT.

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	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1