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 Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer experienced falsely elevated bilirubin results for one patient while using the architect c16000 analyzer.The following data was provided.Initial 8.6 mg/dl; expected result was 0.9 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

The abbott field service representative (fsr) was dispatched to the account after the customer replaced the damaged reagent probe (part 09d48-02) and confirmed the damaged probe.The fsr also found the cuvette drying tips were damaged when the probe was replaced and the cuvette washer was clogged by a piece of the drying tip.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, a device history 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.Device history review did not identify any issues that may have caused the customer issue.The issue was resolved and the analyzer was returned to service.Service history review identified no contributing factors to the customer issue.Based on all available information and abbott diagnostics complaint investigation, the device did not perform as intended.A malfunction of the reagent probe (part 09d48-02) was identified.No product deficiency 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: 6382037
• MDR Text Key: 69208672
• Report Number: 1628664-2017-00055
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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 TOTAL BILIRUBIN; LIST NUMBER 06L45-41; LOT NUMBER 50182UQ10