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

Model Number	3L80-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
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.Phone number: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely depressed carbon dioxide result generated on the architect c16000 processing module for one sample.Results provided: initial result = 6.1 mmol/l, repeat result = 22.9 mmol/l.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, and device history record review.Instrument troubleshooting including washing sample probe and r1 reagent probe was performed.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 62046uq05 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the carbon dioxide assay for lot 62046uq05 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely depressed carbon dioxide result generated on the architect c16000 processing module for one sample.Results provided: initial result = 6.1 mmol/l, repeat result = 22.9 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16831177
• Report Number: 3002809144-2023-00204
• Device Sequence Number: 1929661
• Product Code: KHS
• UDI-Device Identifier: 00380740161538
• UDI-Public: 00380740161538
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/13/2023

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: 06/30/2023
• Device Model Number: 3L80-32
• Device Catalogue Number: 03L80-32
• Device Lot Number: 62046UQ05
• 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: 04/15/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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 C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown