MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY ENZYMATIC CREATININE_3 (ECRE3); ENZYMATIC METHOD, CREATININE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed enzymatic creatinine_3 (ecre3) result was obtained on a patient sample on an advia chemistry xpt system and considered discordant when compared to the other replicates from the same sample.The siemens application service engineer went to the customer site to troubleshoot and observed after changing to a new reagent pack and by checking the reagent (r1) there were some air bubbles on the top.It was noted the discordant lower results were obtained after changing to a new reagent pack.The customer was instructed to check very carefully a new reagent pack for air bubbles before processing patient samples.Siemens healthcare diagnostics is investigating.
Event or Problem Description
A falsely depressed enzymatic creatinine_3 (ecre3) result was obtained on a patient sample on an advia chemistry xpt system and considered discordant when compared to the other replicates from the same sample.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed enzymatic creatinine_3 (ecre3) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00279 on november 03, 2023.An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed enzymatic creatinine_3 (ecre3) result was obtained on a patient sample on an advia chemistry xpt system and considered discordant when compared to the other replicates from the same sample.November 08, 2023 additional information: the initial issue was reported as enzymatic creatinine 3 ( ecre3 lot # 020) discordant results for a patient sample using an advia chem xpt system (serial no: (b)(6).Siemens reviewed the available information in the complaint and the instrument data provided.The customer states that the issue is fixed by removing the bubbles in the reagent before loading.Based on the available information, the probable cause of the enzymatic creatinine 3 (ecre3 lot # 020) discordant results for the patient sample is due to the bubble formation on the reagent which causes discordant results of ecre3, and issue is resolved by removing bubbles before loading.No further evaluation of the device is required.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ADVIA CHEMISTRY ENZYMATIC CREATININE_3 (ECRE3)
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 18064580
• Report Number: 1219913-2023-00279
• Device Sequence Number: 8077935
• Product Code: JFY
• UDI-Device Identifier: 00630414610962
• UDI-Public: 00630414610962
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K212223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 11537235
• Device Lot Number: 020
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown