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 03/22/2023

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 elevated co2 results generated on the architect c4000 processing module for 3 patients.The results were not reported out.The customer repeated the samples after an instrument flush and calibration of the assay and the result was lower.The following data was provided: patient 1 initial result = 30 mmol/l repeat result = 23; patient 2 initial result = 30 mmol/l repeat result = 22; patient 3 initial result = 31 mmol/l repeat result = 26 no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely increased co2 results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A search of complaints by lot number determined normal complaint activity.The tracking and trending were reviewed by the product list number and found no trends related to this issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of the device history records did not identify any nonconformances or deviations associated with current complaint.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or product deficiency for co2 reagent (ln 3l80-22) lot 62947uq10 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: 16690152
• MDR Text Key: 312789840
• Report Number: 3002809144-2023-00184
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62947UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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)