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 Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that an architect magnesium result of >3.9 mmol/l was generated for a patient sample ((b)(4)) that upon retesting generated a normal result (exact value not provided).The customer's normal range is 0.66 to 1.07 mmol/l.Field service identified a leaking probe on the cuvette washer.Control values and precision testing was within specifications after service replaced the probe.No adverse impact to patient management was reported.

Manufacturer Narrative

The abbott field service representative (fsr) was dispatched to troubleshoot the issue.Upon inspection of the analyzer, the fsr observed that cuvette wash nozzle #5 had been leaking.The fsr replaced the nozzle, and then initiated a cuvette wash.There was no evidence of leaking or dripping after the nozzle was replaced.The fsr then recalibrated magnesium and performed a precision run to verify instrument performance.No additional erratic magnesium results were reported on architect (b)(4).A service ticket review for (b)(4) revealed no additional erratic or discrepant results, nor did it identify any service or complaint issues that may have contributed to this issue.Quality metrics were reviewed.No systemic issues or adverse trends for the issue associated with this ticket.(erratic / discrepant results) were identified.The architect system operations manual and the architect service and support manual provide adequate information, troubleshooting, and maintenance concerning erratic/ discrepant results.Based on the available information, a deficiency of the system was not identified.There is no evidence to reasonably suggest a malfunction occurred for the cuvette wash nozzles.The issue was resolved by the field service representative through standard troubleshooting procedures.

• 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: 5141813
• MDR Text Key: 28351877
• Report Number: 1628664-2015-00251
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Followup
• Report Date: 11/06/2015

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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