MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number	03L80-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Complete information for patient information, (b)(6).There is no further patient information obtained from the customer.
Event or Problem Description
The customer reported falsely elevated co2 results on multiple patients.The results provided were for 5 samples: sid (b)(6) = 33.27 / 24.67; (b)(6) = 31.89 / 24.26; sid (b)(6) = 31.75 / 23.68; sid (b)(6) = 32.47 / 24.67; sid (b)(6) = 32.87 / 24.52.There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the manufacturing site in section of this submission is incorrect and has been corrected in mdr number 1628664-2018-00265 which has been submitted.All further information will be documented under that mdr number.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7634405
• Report Number: 1415939-2018-00108
• Device Sequence Number: 13918708
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

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: 09/30/2016
• Device Catalogue Number: 03L80-21
• Device Lot Number: 51686UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1