MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem High Test Results (2457)

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

Event Date 10/03/2017

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 stated that a falsely elevated cc magnesium result of 3.583 mmol/l was generated on the architect c16000 analyzer.The sample was repeated and results of 0.950 and 0.928 mmol/l were generated.There was no report of impact to patient management.

Manufacturer Narrative

No customer returns were available for investigation.A field service representative (fsr) investigated the event onsite and addressed the issue by replacing the cuvette dry tip, tubing, h.C.Waste nozzle a and nozzle b on the architect c16000 analyzer.In addition, the fsr also cleaned the cuvettes and water bath.Field service verified the system function with a control run.There have been no further contacts from the customer regarding discrepant results.Customer complaint data was reviewed and no adverse trends were identified.The architect system operations manual and the cc magnesium reagent package insert were reviewed and were found to adequately address the issue.Based on the available information no product deficiency of the architect c16000 analyzer was identified.

• Brand Name: ARCHITECT C16000 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: 6982540
• MDR Text Key: 90957614
• Report Number: 1628664-2017-00401
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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