MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number	03L80-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer inquired as to whether an elevated triglyceride result (3642 mg/dl) could cause a falsely depressed co2 result of 11 mmol/l for a patient sample tested on the architect c16000 system.The sample tested at 26 mmol/l using an alternate co2 method.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of all complaints associated with the co2 assay (list number 3d80, lot number 53465uq08) and a review for complaint trends and corrective and preventative action records for the list number was performed.The review did not identify any trends associated with this issue.Field data was analyzed and this lot appears to perform acceptably.Additionally, labeling was reviewed and adequately addresses the issue under review.Interferences are listed in the package insert, and while endogenous substances may interfere with this assay, handling and storage may have had an impact also.Based on the available information, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8307829
• Report Number: 1628664-2019-00096
• Device Sequence Number: 986131
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 03L80-31
• Device Lot Number: 53465UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C16000 SYSTEM; ARCHITECT C16000 SYSTEM; LIST 03L77-01, SERIAL C1601630; LIST 03L77-01, SERIAL C1601630