MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 02P24-40

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that the architect analyzer generated a falsely decreased potassium (k) result on one patient.The results provided were: (b)(6) - initial results k=1.6mmol/l / k=4.0 (within customer's normal range).There was no additional patient information provided.There was no reported impact to patient management.

Manufacturer Narrative

Concomitant medical products and therapy dates added the lot number 151023062 of the ict module.An evaluation was performed by reviewing the complaint text, other customer complaints for similar issues, a review of labeling, and a review of historical records.The architect serial number (sn) c401617 instrument logs confirm the falsely depressed potassium, sodium, and chloride issue.The history log shows ict module 151023062, expiration date 23jul2016, was installed on 13jan2016 and was within the use warranty period of 3 months after installation.The ict module performance between 29mar2016 and 01apr2016 was stable and within acceptable limits.A review of service history for architect sn (b)(4) did not reveal any possible causes and no additional reports for erratic or discrepant assay results have been received.A review of all complaints for ict module lot 151023 did not identify any other complaints for similar incidents.A review of all ict module complaints did not identify any related issues or trends.A review of complaints for architect c4000 systems revealed no issues or trends related to the current complaint.A review of product labeling shows adequate information with regard to maintenance, component replacement, specimen collection and handling, result interpretation, and troubleshooting for the reported issue.Based on this investigation, neither a malfunction nor deficiency was identified for architect c401617 or ict module 151023062.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• Brand Name: ARCHITECT C4000 ANALYZER
• 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: 5591745
• MDR Text Key: 44001946
• Report Number: 1628664-2016-00107
• Device Sequence Number: 0
• Product Code: CEM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2016; 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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