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

Catalog Number	03L80-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
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 reported of falsely depressed architect carbon dioxide results for multiple samples.The customer indicated the initial results were approximately 18 mmol/l and retested on a new lot with a results of approximately 22 mmol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
Review of complaint activity determined that there were no other complaints related to falsely depressed results for the likely cause lot.Tracking and trending report review for the carbon dioxide assay determined that there were no related adverse or non-statistical trends.The customer's instrument logs were reviewed.This review found the absorbances for the last calibration with the likely cause lots were lower than previous calibrations, which may indicate possible contamination of the carbon dioxide reagent.Using world wide field data the performance of reagent lot 53082uq05 and calibrator lot 11449fd01 were reviewed and no issues were identified.Manufacturing documentation for the assay was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect carbon dioxide assay 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: 8112107
• Report Number: 1628664-2018-02068
• Device Sequence Number: 11166904
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 06/30/2019
• Device Catalogue Number: 03L80-21
• Device Lot Number: 53082UQ05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 03/08/2019
• 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 C8000 SYSTEM, LIST 01G06-11,; ARCHITECT C8000 SYSTEM, LIST 01G06-11,; SERIAL (B)(4) ; SERIAL (B)(4)