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

Model Number	3L80-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
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.
Event or Problem Description
The customer observed falsely decreased carbon dioxide results for 1 patient processed on the architect c4000 processing module, serial number (b)(6).The customer repeated on another c4000, serial number (b)(6), and the result was higher.The customer provided the following data(all results are from 25may2023): sid 673572014 initial result = 19 repeat result = 24 normal reference range is 22-29 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
On 27jun2023, the customer provided additional information.The customer replaced a part on their water system causing discrepant results again.The customer is no longer questioning the architect co2 reagent.The customer states they know the issue is regarding the water system.Based upon this new information, this complaint is no longer a reportable event and no additional information will be submitted.
Event or Problem Description
The customer observed falsely decreased carbon dioxide results for 1 patient processed on the architect c4000 processing module, serial number (b)(6).The customer repeated on another c4000, serial number (b)(6), and the result was higher.The customer provided the following data(all results are from (b)(6) 2023): sid (b)(6) initial result = 19 repeat result = 24 normal reference range is 22-29 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: 17107851
• Report Number: 3002809144-2023-00263
• Device Sequence Number: 19376584
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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 Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 63095UQ10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown