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

Catalog Number 08C89-01

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a falsely elevated afp result for one patient while using the architect i2000 analyzer.The following data was provided (ng/ml).(b)(6) 2016: initial 127.10, retests 2.70, 2.40 and 2.40.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.Based on all available information and abbott diagnostics' complaint investigation, the analyzer performed as intended and no product deficiency was identified.

Manufacturer Narrative

Conclusion code changed from 71 to 75.The device evaluation was reassessed and concluded that a malfunction occurred.However, no systemic issue or product deficiency was identified for the architect i2000 analyzer, list number 08c89.

• 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: 5404284
• MDR Text Key: 37341782
• Report Number: 1628664-2016-00027
• Device Sequence Number: 0
• Product Code: CDZ
• 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,Followup
• Report Date: 04/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1