MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C8000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 01G06-11

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated sodium patient results while using the architect c8000 analyzer ict module.The following data was provided.The customer uses normal range 133 to 143, critical greater than 160.Sid (b)(6) initial 161, repeat using two different analyzers 163, 163 inova method was lower, 141, and the advia method was similar, 161.The normal range for these methods was not provided.An additional specimen was drawn at another location and was lower, 143, using the architect method.The historical result for this patient is normally around 140.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling review, instrument log review, and an instrument service review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Service history review identified no contributing factors to the customer issue.Based on all available information and the evaluation, no systemic issue was identified and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that no malfunction occurred, the device did perform as intended.On july 24, 2017, the customer informed abbott customer support that the original sample was collected in a sodium citrate tube instead of lithium heparin tube which caused interference with the sodium results for sid 17061207178.Product labeling does not include sodium citrate as an acceptable anticoagulant collection vessel for use with the test.

• Brand Name: ARCHITECT C8000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY 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: 6671740
• MDR Text Key: 78555480
• Report Number: 1628664-2017-00273
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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