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

Model Number 3L80-22

Device Problem Low Test Results (2458)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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 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
• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17107851
• MDR Text Key: 317142868
• Report Number: 3002809144-2023-00263
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)