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

Catalog Number 03L80-22

Device Problem High Test Results (2457)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

The customer observed a falsely elevated carbon dioxide (co2) result for one sample generated on generated on the architect c4000 processing module.The sample was originally questioned by the physician due to a low ion gap result.The following data was provided: co2 initial result = 30 mmol/l, repeat = 28 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

After further review, section d4 lot # was updated from 64862uq0 to 64862uq08.H3 other text : device evaluation started but not yet completed.

Event Description

The customer observed a falsely elevated carbon dioxide (co2) result for one sample generated on generated on the architect c4000 processing module.The sample was originally questioned by the physician due to a low ion gap result.The following data was provided: co2 initial result = 30 mmol/l, repeat = 28 mmol/l no impact to patient management was reported.

Event Description

The customer observed a falsely elevated carbon dioxide (co2) result for one sample generated on generated on the architect c4000 processing module.The sample was originally questioned by the physician due to a low ion gap result.The following data was provided: co2 initial result = 30 mmol/l, repeat = 28 mmol/l no impact to patient management was reported.

Manufacturer Narrative

Section d4 unique identifier (udi) was updated from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 64862uq08.Ticket trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with lot 64862uq08 and issue.The overall performance of the carbon dioxide was reviewed using field data from customers worldwide.Review found that the patient median values obtained with lot 64862uq08 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the carbon dioxide for reagent lot 64862uq08 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: 18684905
• MDR Text Key: 335117455
• Report Number: 3002809144-2024-00034
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: (01)00380740161521(17)240930(10)64862UQ08
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2024

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 Catalogue Number: 03L80-22
• Device Lot Number: 64862UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 05/02/2024
• Supplement Dates FDA Received: 03/18/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C461476; ARC C4 PROC MOD, 02P24-01, C461476; ARC C4 PROC MOD, 02P24-01, C461476