MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2); 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	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information (05-jun-2025): siemens service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer and the data from the instrument.No reagent or instrument issues were identified.The customer ran quality control (qc) after processing the samples, which was out of range, low.Review of the calibration data showed low recovery for the calibrator.Calibration was performed as a standard troubleshooting procedure.Qc recovery was within the customer¿s expected ranges after the new calibration.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2025-00135 was filed on 20-may-2025.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed (below the measuring interval) creatinine_2 (crea_2) results obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained erroneously depressed (below the measuring interval) creatinine_2 (crea_2) patient sample results on an atellica ch 930 analyzer.The erroneously depressed patient.Results were not reported to the physician(s).The same samples were reprocessed on an alternate atellica ch 930 analyzer.Higher results obtained, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed creatinine_2 (crea_2) results.

• Brand Name: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 22053049
• Report Number: 2432235-2025-00135
• Device Sequence Number: 20169229
• Product Code: JFY
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242278(17)250901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 09/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 242278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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