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

Model Number 3L80-22

Device Problem High Test Results (2457)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6) (2 patients).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated carbon dioxide (co2) results for 2 patients while running on the architect c8000 processing module.The following data was provided: on (b)(6) 2021 sid (b)(6): initial co2 result: 30.9 meq/l, repeat on another analyzer: 23.7 meq/l.On (b)(6) 2021 sid (b)(6): initial co2 result: 31.4 meq/l, repeat on another analyzer: 25.8 meq/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated carbon dioxide results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The lot search did not identify an increase in complaint activity for the current complaint issue.Trending was reviewed and did not identify any trends for the product for the issue.File sample analysis was not performed.As part of troubleshooting, the patient samples were tested on a different system and gave lower results.Quality control (qc) material that initially generated elevated results is now generating acceptable results and the complaint issue was reported to be resolved.The device history recorded was reviewed and did not identify any non-conformances or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for carbon dioxide reagent lot 60106uq07 was identified.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13059687
• MDR Text Key: 286878777
• Report Number: 3002809144-2021-00712
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 08/31/2022
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 60106UQ07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C803309; ARC C8 PROC MOD, 01G06-11, C803309