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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and instrument service.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 standard troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation, the analyzer performed as intended and no product deficiency was identified.This issue was previously reported under mdr number 1628664-2016-00227 under a different suspect device.

Event Description

The customer observed false elevated magnesium patient results generated using the architect c8000 analyzer.The following data was provided.The customer uses normal range 0.7 to 1.0 mmol/l.Sid (b)(4) initial greater than 3.9, repeat 0.65 results other analyzer (serial number (b)(4) 0.6.No impact to patient management was reported.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product 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: 6110835
• MDR Text Key: 60310505
• Report Number: 1628664-2016-00284
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/25/2017

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: 01G06-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• 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
• Treatment: CLINICAL CHEMISTRY MAGNESIUM; LIST NUMBER (B)(4); LOT NUMBER 91900UN15