MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	04S95-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in-house testing of retained reagent kit and labeling 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 search for similar complaints for lot 54211ud00 did not identify an increase in complaint activity for the issue.The ticket trending review for lot 54211ud00 did not identify any trend regarding commonalities for the issue under review.A device history record review did not identify any non-conformances or deviations associated with the lot number 54211ud00 and complaint issue.In-house accuracy testing was completed with retained complaint lot number 54211ud00.All validity and acceptance criteria as per the protocol were met and the product is performing as expected.Labelling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the creatinine2 reagent lot 54211ud00 was identified.
Event or Problem Description
The customer reported a discrepant creatinine2 result generated on the architect c4000 analyzer on a patient.Results provided: pt 4 (56-yr old female) = 1.88 / 5.02 / 4.02 / 4.96 / 4.98 / 5.09 mg/dl.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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a discrepant creatinine2 result generated on the architect c4000 analyzer on a patient.Results provided: pt 4 (56-yr old female) = 1.88 / 5.02 / 4.02 / 4.96 / 4.98 / 5.09 mg/dl no impact to patient management was reported.

• Brand Name: CREATININE2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19565762
• Report Number: 3005094123-2024-00335
• Device Sequence Number: 20409723
• Product Code: CGX
• UDI-Device Identifier: 00380740159535
• UDI-Public: (01)00380740159535(17)241010(10)54211UD00
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K210452
• 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): 07/12/2024

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: 10/10/2024
• Device Catalogue Number: 04S95-20
• Device Lot Number: 54211UD00
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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 C4 PROC MOD, 02P24-01, C461815; ARC C4 PROC MOD, 02P24-01, C461815
• Patient Age: 56 YR
• Patient Sex: Female