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

Catalog Number	03L80-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
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 reported falsely elevated bicarb/co2 generated from an architect c4000 that was normal when ran on another analyzer.The customer provided the following data: patient reference range (20-29) meq/l sample 1: initial run >50, reran >50.When repeated on another analyzer the result was 27 sample 2: initial: 45, rerun 45.When repeated on another analyzer the result was within normal range (no value provided) the customer reported that they recalibrated the assay, which resolved the issue.Sample 1 result after recalibrations was 27 & sample 2 result after recalibrations was 20.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
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.The ticket search by complaint lot and trending review did not identify an increase in complaints device history review did not identify any non-conformance's or deviations with the complaint lot.The overall performance of the co2 reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 65440uq12 is within established limits and thus comparable to the historical lot performance.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the co2 reagent lot 65440uq12 was identified.
Event or Problem Description
The customer reported falsely elevated bicarb/co2 generated from an architect c4000 that was normal when ran on another analyzer.The customer provided the following data: patient reference range (20-29) meq/l sample 1: initial run >50, reran >50.When repeated on another analyzer the result was 27 sample 2: initial: 45, rerun 45.When repeated on another analyzer the result was within normal range (no value provided) the customer reported that they recalibrated the assay, which resolved the issue.Sample 1 result after recalibrations was 27 & sample 2 result after recalibrations was 20.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

• 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: 19995747
• Report Number: 3002809144-2024-00237
• Device Sequence Number: 6964409
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: (01)00380740161521(17)250131(10)65440UQ12
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 03L80-22
• Device Lot Number: 65440UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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 C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown