FDA Adverse Event Malfunction Summary report: N

ARCHITECT I2000SR ANALYZER

MDR report key: 1080264 · Received July 22, 2008

Report

Report Number: 1628664-2008-00176
Event Type: Malfunction
Date Received: July 22, 2008
Date of Event: June 21, 2008
Report Date: June 25, 2008
Manufacturer: ABBOTT MANUFACTURING, INC.
Product Code: JJE
PMA / PMN Number: K983212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative · 1

(B)(4). IN- HOUSE TESTING WAS PERFORMED. WHEN (B)(4) WERE GENERATED, THE CUSTOMER'S ALLEGED INCIDENT OF THE ARCHITECT I2000SR CHANGING THE CARRIER POSITION OF THE SAMPLE IDENTIFICATION (SID) WAS UNABLE TO BE REPRODUCED. THE IN-HOUSE TESTING SHOWED THAT THE SOFTWARE IS PERFORMING AS INTENDED. IN ADDITION A REVIEW OF THE CUSTOMER'S RETURNED SYSTEM LOGS AND DATABASE WAS PERFORMED AND THE ISSUE WAS UNABLE TO BE CONFIRMED. THE COMPLAINT ANALYSIS AND TRENDING SYSTEM (CATS) AND THE ARCHITECT PROBLEM REPORTING SYSTEM (PRS) DATABASES WERE REVIEWED AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. NO MALFUNCTION WAS IDENTIFIED. THIS IS THE FINAL REPORT.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT WHEN THE ARCHITECT ANALYZER GENERATES ERROR CODE 3350 (UNABLE TO PROCESS TEST, ASPIRATION ERROR) THE INSTRUMENT CHANGES THE POSITION OF THE IDENTIFICATION OF THE SAMPLES. THE CUSTOMER HAS TO REPEAT THE ENTIRE RUN DUE TO POSSIBLE IDENTIFICATION ERRORS. THERE WAS NO REPORT OF INCORRECT RESULTS BEING GENERATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARCHITECT I2000SR ANALYZER	AUTOMATED IMMUNOASSAY ANALYZER	JJE	ABBOTT MANUFACTURING, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI