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

Catalog Number	03L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated co2 results generated on the architect c4000 analyzer on multiple patients on (b)(6) 2023.The following results were provided: sid: result / repeat: (b)(6) = 30.245 / 25.229 mmol/l, (b)(6) = 33.157 / 24.250 mmol/l, (b)(6) = 29.765 / 29.874/ 23.772 / 22.543 mmol/l, (b)(6) = 33.451 / 23.784 mmol/l, (b)(6) = 31.281 / 19.103 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The complaint investigation for falsely elevated co2 results included a review of data and information provided by the customer, labeling review, search for similar complaints, ticket trending review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Manufacturing documentation (device history record) for the likely cause did not identify any issues associated with the complaint issue.This indicates the assay is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no deficiency was identified.G1 update to contact information.
Event or Problem Description
The customer reported falsely elevated co2 results generated on the architect c4000 analyzer on multiple patients on (b)(6) 2023.The following results were provided: sid result / repeat (b)(6) = 30.245 / 25.229 mmol/l (b)(6) = 33.157 / 24.250 mmol/l (b)(6) = 29.765 / 29.874/ 23.772 / 22.543 mmol/l (b)(6) = 33.451 / 23.784 mmol/l (b)(6) = 31.281 / 19.103 mmol/l 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17718503
• Report Number: 3002809144-2023-00390
• Device Sequence Number: 7163589
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 10/11/2023

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: 03/31/2024
• Device Catalogue Number: 03L80-22
• Device Lot Number: 63532UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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, C401915; ARC C4000 INTGR, 02P24-40, C401915
• Patient Sex: Unknown