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

Model Number	3L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
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 elevated co2 results for 6 patients that were questioned by a physician.Of note, the results were normal after removing the coefficient and the qcs also skewed high.The following data was provided (reference range 22-29 mmol/l): sid 1 34.3 mmol/l, repeat after removing coefficient 25.4 mmol/l.Sid 2 35.1 mmol/l, repeat after removing coefficient 26.0 mmol/l.Sid 3 31.2 mmol/l, repeat after removing coefficient 23.1 mmol/l.Sid 4 32.5 mmol/l, repeat after removing coefficient 24.1 mmol/l.Sid 5 32.8 mmol/l, repeat after removing coefficient 24.3 mmol/l.Sid 6 34.3 mmol/l, repeat after removing coefficient 25.4 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Return testing was not performed as returns were not available.Device history record review was performed on lot 62208uq06, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Historical performance of carbon dioxide reagent lot number 62208uq06 was evaluated using world wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot number 62208uq06 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Labeling was reviewed and found to adequately address the issue under review.As part of troubleshooting the samples were rerun with acceptable results after the correlation factor was corrected.Based on all reviewed data, we conclude that there is no product deficiency with the architect carbon dioxide reagent identified in this complaint.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15991308
• Report Number: 3002809144-2022-00440
• Device Sequence Number: 5672229
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 07/31/2023
• Device Model Number: 3L80-22
• Device Catalogue Number: 03L80-22
• Device Lot Number: 62208UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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