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

Catalog Number 01G06-97

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated magnesium results while using the architect c8000 analyzer.The following data was provided: (b)(6), initial 2.78 mmol/l, repeat using the same analyzer 0.91 mmol/l, repeat using another analyzer 0.89 mmol/l.During troubleshooting, the customer noticed excess fluid on the analyzer reaction carousel that seemed to come from the cuvette washer hc waste nozzle.No injury or exposure was reported due to the excess fluid and no impact to patient management was reported.

Manufacturer Narrative

An abbott field service representative (fsr) was dispatched to the account and found the poppet set valve (part 09d36-02) was worn from normal use.The poppet set valve (part 09d36-02) was replaced and the fsr verified system function with a control run.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling 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.The issue was resolved through by replacing a part [valve, poppet set part 09d36-02].Service history review identified no contributing factors to the customer issue.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• 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: 6901846
• MDR Text Key: 88935732
• Report Number: 1628664-2017-00361
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980367
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01G06-97
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• 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