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 12/01/2022

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 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.

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
• 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: 15991308
• MDR Text Key: 308271762
• Report Number: 3002809144-2022-00440
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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).