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

Model Number	3L80-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
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 depressed co2 results generated on the architect c4000 instrument.They tested within the critical range on the c4000 and when repeated on the c8000 (b)(4) are within normal range.The following data was provided: sid (b)(6).Initial 15.8 on c4100 repeat 18 on c8200 istat 22* (customer is unsure of the exact value but md claims it was within normal range) normal range 22 ¿ 29, uom mmol/l).The patient did not receive any treatment based on initial false results.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 62947uq10, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.As part of the troubleshooting the sample was retested on another platform c8000 (sn (b)(6) using the same reagent lot and a result of 18 mmol/l was generated, results on c4 and c8 were compared with results on the istat which generated a result of approximately 22 mmol/l.The lab was questioning the resistivity on their water system and troubleshooting was performed to resolve resistivity.After replacing the reagent pack and fresh calibration no further issue was seen.In addition, review of the data associated with lot number 62947uq10 indicate the patient median is within 2 sd of the established baseline.Therefore, no unusual reagent lot performance was identified for lot number 62947uq10.Labeling was found to be adequate for the issue under review.Based on the investigation, no systemic issue or deficiency of the co2 assay was identified.Corrected data found in section d4 catalog # (changed from 03l80-31 to 03l80-22).
Event or Problem Description
The customer observed falsely depressed co2 results generated on the architect c4000 instrument.They tested within the critical range on the c4000 and when repeated on the c8000 (sn (b)(6) are within normal range.The following data was provided: sid (b)(6).Initial 15.8 on c4100.Repeat 18 on c8200.Istat 22 (customer is unsure of the exact value but md claims it was within normal range) normal range 22 ¿ 29, uom mmol/l).The patient did not receive any treatment based on initial false results.No impact to patient management was reported.

• Brand Name: CARBON DIOXIDE
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16610214
• Report Number: 3016438761-2023-00155
• Device Sequence Number: 6148883
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 11/30/2023
• Device Model Number: 3L80-31
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62947UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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 C4000 INTGR, 02P24-40, C402008.; ARC C4000 INTGR, 02P24-40, C402008.
• Patient Sex: Unknown