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

Catalog Number	03L80-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002809144-2023-00414
• Device Sequence Number: 7695705
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: 00380740161521
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/12/2023
• 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 C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown