MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000 ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 08C89-01

Device Problem False Device Output (1226)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The account generated (b)(6) on a patient sample that repeated (b)(6) on the architect i2000 analyzer.No specific patient information is available.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

The field service representative replaced three valves on wash zone 2 and the pressure sensor due to being worn out from normal use on the architect i2000 analyzer.The field service representative determined the three valves on wash zone 2 were the most likely cause of the result issue which was resolved through normal troubleshooting procedures.No customer return was available for investigation.A review of the subsequent instrument service history revealed no additional complaints of erratic or discrepant results have been documented.Nor did the service history review identify a contributing cause of the issue currently under investigation.The architect system operations manual and architect (b)(6) package insert provides adequate information with respect to the issue.The 12 month tracking/ trending review of the valves did not identify an adverse trend.This issue was isolated to a single sample; therefore, a possible issue with sample handling cannot be ruled out.No product deficiency was identified with the valves or the architect i2000 analyzer.

• Brand Name: ARCHITECT I2000 ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4167788
• MDR Text Key: 5022328
• Report Number: 1628664-2014-00223
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08C89-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) LIST (B)(4); LOT 40382LI00; LOT 40382LI00; (B)(6) LIST (B)(4)