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

Catalog Number	03L80-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
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 account generated a falsely elevated patient result for architect carbon dioxide and when repeated was normal.The customer provided (b)(6): initial result 33 meq/l and same day repeat result 28 meq/l (account normal range 23-31meq/l).No impact to patient management reported.The account does not know specific patient information.
Additional Manufacturer Narrative
The customer performed instrument troubleshooting since their quality control (qc) seemed to drift out of range before calibration expiration.After troubleshooting the qc performance improved, but the qc values again drifted upward when the co2 test count drop down to about 50.Further investigation of the customer issue included a review of associated complaints, a review for complaint trends, a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.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: 7895185
• Report Number: 1628664-2018-01894
• Device Sequence Number: 19309825
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/22/2019

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: 05/31/2019
• Device Catalogue Number: 03L80-31
• Device Lot Number: 52780UQ04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1