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

Catalog Number	SMN 11537216
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated enzymatic creatinine_3 (ecre3) patient sample result on an atellica ch 930 analyzer.The erroneously elevated result was not reported to the physician(s).The same sample was reprocessed on the same atellica ch 930 analyzer.The lower reprocessed result obtained was considered correct and reported to the physician(s).Customer stated that the patient discharge was delayed due to the event and confirmed that there was no adverse effect or impact on patient care due to the event.There are no known reports of adverse health consequences due to the erroneously elevated enzymatic creatinine_3 (ecre3) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated enzymatic creatinine_3 (ecre3) patient sample result obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (06-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Calibration and quality control (qc) recovery were within the customer¿s expected ranges.The instrument data showed no process errors on the analyzer that would indicate a hardware issue, and no issues were identified with the level sense.Aspiration data did not show any abnormalities with the reagent, dilution, and sample arms indicating the reagent and the sample were successfully aspirated and delivered.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00080 was filed on 25-apr-2024.

• 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: 19180890
• Report Number: 2432235-2024-00080
• Device Sequence Number: 12615519
• Product Code: JFY
• UDI-Device Identifier: 00630414610948
• UDI-Public: 00630414610948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/30/2024

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: 11/25/2024
• Device Catalogue Number: SMN 11537216
• Device Lot Number: 130345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: 67 YR
• Patient Sex: Male