MAUDE Adverse Event Report: ABBOTT GMBH CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE

Model Number	3L80-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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 observed falsely depressed co2 results generated on the architect c4000 processing module for multiple samples that were questioned by the physician.Additionally, the customer noted a shift in quality controls.The following data was provided (units of measure is mmol/l): sid 79217 initial co2 result = 21, repeat = 25.Sid 79215 initial co2 result = 20, repeat = 24.Sid 79177 initial co2 result = 19, repeat = 22.Sid 79167 initial co2 result = 20, repeat = 23.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed carbon dioxide results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 62769uq08 and the complaint issue.The overall performance of carbon dioxide was reviewed using field data from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 62769uq08 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 62769uq08.Labeling was reviewed and sufficiently addresses the customer's issue.New reagents were loaded and recalibrated and the quality control) qc for all three levels were well within in range.As part of the troubleshooting precision runs were performed and were within the %cv specification.The samples were repeated with the new reagent pack and the results were within normal ranges.Customer states there have been no further issues with patients or controls results.Based on our investigation, no systemic issue or deficiency with the carbon dioxide assay for lot 62769uq08 was identified.
Event or Problem Description
The customer observed falsely depressed co2 results generated on the architect c4000 processing module for multiple samples that were questioned by the physician.Additionally, the customer noted a shift in quality controls.The following data was provided (units of measure is mmol/l): sid (b)(6) initial co2 result = 21, repeat = 25; sid (b)(6) initial co2 result = 20, repeat = 24; sid (b)(6) initial co2 result = 19, repeat = 22; sid (b)(6) initial co2 result = 20, repeat = 23.No impact to patient management was reported.

• Brand Name: CARBON DIOXIDE
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16954354
• Report Number: 3002809144-2023-00239
• Device Sequence Number: 7013229
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 09/30/2023
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62769UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C4000 INTGR, 02P24-40, (B)(6).; ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown