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

Catalog Number 03L80-22

Device Problem Low Test Results (2458)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

The customer observed falsely decreased carbon dioxide results for 3 patients using reagent lot 62947uq10 when compared to same patients results using reagent lot 63532uq02.The results were released but were within the customers permitted bias %.The customer provided the following data: sid (b)(6) bias% 1 22.3 21.2 -4.93, 3 22.6 21.2 -6.19, 4 23.3 21.5 -7.73.Normal reference range is 22-29 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = sid 1, 3, and 4.

Event Description

The customer observed falsely decreased carbon dioxide results for 3 patients using reagent lot 62947uq10 when compared to same patients results using reagent lot 63532uq02.The results were released but were within the customers permitted bias %.The customer provided the following data: sid (b)(6) 62947uq10 bias% 1 22.3 21.2 -4.93; 3 22.6 21.2 -6.19, 4 23.3 21.5 -7.73.Normal reference range is 22-29 mmol/l 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, field data 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.To further investigate the customer¿s issue, the historical performance of reagent lot 62947uq10 was evaluated using worldwide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 62947uq10 is within 2 sd of the established baseline indicating that the lots is performing acceptably in the field.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17834989
• MDR Text Key: 324488373
• Report Number: 3002809144-2023-00414
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 12/12/2023

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62947UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/12/2023
• 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 C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)