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

Catalog Number 01G06-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

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 >6.5 mg/dl was generated for a patient sample that retested at 2.1 mg/dl twice.The initial result was not reported out of the laboratory.No adverse impact to patient management was reported.

Manufacturer Narrative

Technical customer support advised the customer to replace the cuvette drying tip which was found to be discolored.Quarterly maintenance and cuvette cleaning were performed on 08/18/2015 by the field service engineer.The customer confirmed no additional discrepant magnesium results generated since customer replacement of the cuvette drying tip.The architect system operations manual provides information regarding maintenance, component replacement, limitations of result interpretation, and troubleshooting the reported issue.Service and maintenance provides instructions for removing and replacing the cuvette drying tip.Review of historical quality metrics revealed no systemic issues or adverse trends associated with the discrepant result issue described in this complaint.The complaint investigation information does not reasonably suggest that a device malfunction caused the discrepant high magnesium result.The customer resolved the issue by performing troubleshooting which included replacing a discolored cuvette drying tip and performing maintenance in accordance with the architect system operations manual.No deficiency was identified.

• 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: 5056954
• MDR Text Key: 26010786
• Report Number: 1628664-2015-00226
• Device Sequence Number: 0
• Product Code: JGJ
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 09/16/2015

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: 01G06-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2015
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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