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

Model Number	3L80-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier does not contain enough spaces.The entire id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
Event or Problem Description
The account generated elevated architect carbon dioxide of 30 mmol/l on sid (b)(6) that repeated 27 mmol/l at a reference lab.Historical carbon dioxide patient results were 28 mmol/l ((b)(6) 2017), 24 mmol/l ((b)(6) 2017), 25 mmol/l ((b)(6) 2017), 28 mmol/l ((b)(6) 2016).No impact to patient management was reported.
Additional Manufacturer Narrative
(b)(4).A search by product lot found no complaints similar to this complaint issue.The trend review by the product list number found no adverse or non-statistical trends related to this issue.Review of patient data in the field shows the co2 patient population result medians are similar across multiple customers, instruments, and reagent lots.Review of product labeling revealed adequate labeling for the handling of reagents, handling of patient samples, interpretation of assay results, and troubleshooting this complaint issue.The architect system operations manual provides information about the limitations of result interpretations.A product deficiency was not 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: 7632770
• Report Number: 1628664-2018-00241
• Device Sequence Number: 11145302
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: (01)00380740005955(17)181231(10)52120UQ11
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/19/2018

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: 12/31/2018
• Device Model Number: 3L80-21
• Device Catalogue Number: 03L80-21
• Device Lot Number: 52120UQ11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR