MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C8000 SYSTEM

Catalog Number 01G06-11

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The customer reported that unspecified treatment was administered to some patients (actual number of patients impacted was not provided) after generating falsely decreased magnesium results while using the architect c8000 analyzer.No data was provided to indicate the type of treatment given or any information indicating whether there was any impact to patients as a result of treatment received.Additional information was unavailable from the customer.If more specific patient data is provided, the information will be communicated in a follow-up medical event report.

Manufacturer Narrative

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

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint data, abbott field service engineer (fse) evaluation, a search for similar complaints, and a review of labeling.An abbott field service engineer determined the issue was due to a leaking valve and replaced it.Review of the service ticket history did not identify any other issues that may have contributed to the complaint issue.The wash solution pump valves are commonly replaced as part of preventive maintenance or to address fluidics or results issues.No issues requiring further action or adverse trends were identified for the valve.Tracking and trending did not identify an adverse trend related to falsely decreased magnesium results.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect c8000 analyzer, list number 01g06, was identified.

• Brand Name: ARCHITECT C8000 SYSTEM
• 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 ; 847937-512
• MDR Report Key: 3622196
• MDR Text Key: 4177121
• Report Number: 1628664-2014-00020
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 02/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLINICAL CHEMISTRY MAGNESIUM; LN 07D70-21, LOT UNKNOWN
• Patient Outcome(s): Other