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

Model Number 3L80-22

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 315947897
• Report Number: 3002809144-2023-00239
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6).; ARC C4000 INTGR, 02P24-40, (B)(6).