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

Model Number 3L80-22

Device Problem High Test Results (2457)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated carbon dioxide (co2) results generated on the architect c4000 processing module for multiple samples that were questioned by the physician.There were approximately 5 patients with co2 results that generated results >30 mmol/l (reference range is 22 to 29 mmol/l).The following example data was provided: patient a: initial result = (b)(6) mmol/l, repeat = (b)(6) mmol/l.Samples were sent to a reference laboratory for comparative testing: (b)(6) 2022 sid (b)(6) initial result = (b)(6) mmol/l, reference lab result = (b)(6) mmol/l.(b)(6) 2022 sid (b)(6) initial result = (b)(6) mmol/l, reference lab result = (b)(6) mmol/l.(b)(6) 2022 sid (b)(6) initial result = (b)(6) mmol/l, reference lab result = (b)(6) mmol/l.(b)(6) 2022 sid (b)(6) initial result = (b)(6) mmol/l, reference lab result = (b)(6) mmol/l.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated 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.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 60300uq08 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The water system results show a high co2 content.Based on our investigation, no systemic issue or deficiency with the carbon dioxide assay for lot 60300uq08 was identified.

• 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: 14213470
• MDR Text Key: 290145805
• Report Number: 3002809144-2022-00138
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 60300UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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)