FDA Adverse Event Malfunction Summary report: N

ACCESS® 2 IMMUNOASSAY ANALYZER

MDR report key: 1900803 · Received November 16, 2010

Report

Report Number: 2122870-2010-00758
Event Type: Malfunction
Date Received: November 16, 2010
Date of Event: October 18, 2010
Report Date: November 16, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: LTJ
PMA / PMN Number: K922823/A007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

QC WAS WITHIN THE ESTABLISHED RANGES. WHILE TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS DISCOVERED THAT THE DERIVED RESULT FORMULA WAS ENTERED AS (FREE PSA/PSA)/100 WHILE THE CORRECT FORMULA PER THE INSTRUCTION FOR USE IS (FREE PSA/PSA)*100. THE CTS ASSISTED THE CUSTOMER ENTERING THE CORRECT FORMULA. SINCE CORRECTING THE FORMULA THE CUSTOMER HAS OBTAINED THE CORRECT DERIVED RESULTS FOR THE PATIENTS. THE ROOT CAUSE FOR THIS EVENT WAS USE ERROR OF USING WRONG FORMULA.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOWER THAN EXPECTED % FREE PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR FIFTEEN PATIENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. A SUBSEQUENT TESTING AFTER CHANGING RESULT FORMULA PRODUCED HIGHER RESULTS IN A DIFFERENT DIAGNOSTIC CATEGORY THAT BETTER MATCHED THE PATIENTS' CLINICAL PRESENTATIONS. 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 ANALYZER	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	LTJ	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1