MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	03L81-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.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 creatinine results generated on the architect c4000 processing module for one patient sample.The following data was provided: tested on (b)(6) 2024 (creatinine normal range: 0.5-1.5 mg/dl).Sid (b)(6): creatinine initial result = 2.125 mg/dl; creatinine repeat result = 0.800 mg/dl.There was no impact to patient management reported.
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, and device history record 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 lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the creatinine reagent lot 21504un23 was identified.
Event or Problem Description
The customer observed falsely elevated creatinine results generated on the architect c4000 processing module for one patient sample.The following data was provided: tested on (b)(6) 2024 (creatinine normal range: 0.5-1.5 mg/dl).Sid (b)(6): creatinine initial result = 2.125 mg/dl; creatinine repeat result = 0.800 mg/dl.There was no impact to patient management reported.

• Brand Name: CREATININE
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: 19315569
• Report Number: 3002809144-2024-00142
• Device Sequence Number: 15204691
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: (01)00380740161552(17)250318(10)21504UN23
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083809
• 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): 06/27/2024

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: 03/18/2025
• Device Catalogue Number: 03L81-23
• Device Lot Number: 21504UN23
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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 C4000 INTGR, 02P24-40, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown