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

Model Number	3L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13059687
• Report Number: 3002809144-2021-00712
• Device Sequence Number: 16500589
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2021
• 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 C8 PROC MOD, 01G06-11, C803309; ARC C8 PROC MOD, 01G06-11, C803309
• Patient Sex: Unknown