MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated falsely depressed potassium of 1.5 mmol/l when processing on architect c16000.The sample repeated within the expected normal range on another analyzer.No impact to patient management was reported.No specific patient information was reported.

Manufacturer Narrative

Patient identifier is updated to (b)(6).A review of the product labeling, log review, historical complaints and manufacturing documentation was performed.The sample id (b)(6) was provided in the complaint text however, review of the result log from 10/16/2017 to 10/20/2017 found no result under this id number on the architect c1600846 analyzer for falsely decreased potassium of 1.5 mmol/l results on one patient.Review of the history log shows numerous (177) occurrences of error code 3375 (aspiration error) from september 01, 2017 to october 20, 2017.Inadequate clotting and/or centrifugation times may affect instrument performance, generating errors such as error code 3375.Possible causes for this error include bubbles, foam, or fibrin clots present in the sample.An occurrence of this error with no assignable instrument cause suggests an issue with sample preparation.System factors can also impact patient results.The history log shows (68) occurrences of error code 0550 (instrument hard stops) during the same time frame.Failure to allow cuvette washing to complete (error code 0550) will result in dirty cuvettes and cuvette dryer tips which may affect future assay results and performance.Review of the maintenance log shows the customer has not performed, as suggested by the architect operations manual after each 0550 error, as needed maintenance (6052) wash cuvettes during october 2017.The log analysis indicates a possible sample handling issue rather than the ict diluent.No adverse or non-statistical trends were identified for this assay related to this issue.The trend review and lot search did not identify an increase in complaint activity for the current issue for the complaint lot.No nonconformnaces related to this issue were identified.Review of product labeling revealed adequate labeling for the handling of reagents, samples, interpretation of assay results, and troubleshooting this complaint issue.Use error may have contributed to the customer's issue as it appears to be sample specific.A systemic issue and/or product deficiency was not 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: 6983336
• MDR Text Key: 91074460
• Report Number: 1628664-2017-00402
• Device Sequence Number: 0
• Product Code: CEM
• 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: 12/01/2017

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• 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