MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) erroneously elevated enzymatic creatinine_3 (ecre3) results on a patient sample obtained on an atellica ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.Quality control (qc) recovered within the customer¿s expected ranges.No process errors were observed, and the instrument data showed that the reagents were tracking down as expected with no unexpected transitions.Hsc observed that there were no issues with the atellica ch 930 analyzer nor the ecre3 assay.The cause of the event is unknown.The analyzer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained two (2) erroneously elevated enzymatic creatinine_3 (ecre3) results on a patient sample on an atellica ch 930 analyzer.The erroneously elevated results were reported to the physician(s), and the results were questioned.A new sample was drawn from the same patient, processed, and then reprocessed on an alternate system on subsequent days in another laboratory.Lower results were obtained and considered correct.One of the lower results from the alternate system was reported as the correct result to the physician(s).The customer stated that the patient was hospitalized for 2 days based on the erroneously elevated ecre3 results.No unnecessary medical procedure or treatment was performed on the patient.The patient was under observation in the hospital and was released.There are no known reports of adverse health consequences due to the erroneously elevated enzymatic creatinine_3 (ecre3) results.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3)
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19153305
• Report Number: 2432235-2024-00076
• Device Sequence Number: 18254204
• Product Code: JFY
• UDI-Device Identifier: 00630414610948
• UDI-Public: 00630414610948
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 04/22/2024

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: 07/15/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11537216
• Device Lot Number: 130153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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 Age: 42 YR
• Patient Sex: Male