MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH ALBUMIN BCP (ALBP)

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	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained erroneously depressed albumin bcp (albp) results on three (3) patient samples when processed on an atellica ch 930 analyzer.Two of the patient sample results were reported to the physician and questioned.The patient samples were reprocessed on an alternate atellica ch 930 analyzer.Higher results were obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed albumin bcp (albp) results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneously depressed results with albumin bcp (albp) on three (3) patients on an atellica ch 930 analyzer.Siemens healthcare diagnostics is investigating the event.
Additional Manufacturer Narrative
Additional information (13-jan-2025): siemens service operations support (sos) concluded the investigation of the event.Sos reviewed the available information provided by the customer.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s laboratory ranges at the time of the event.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 2432235-2024-00364 was filed on 27-dec-2024.

• Brand Name: ATELLICA CH ALBUMIN BCP (ALBP)
• Common Device Name: ALBUMIN
• 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; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 21029236
• Report Number: 2432235-2024-00364
• Device Sequence Number: 14470851
• Product Code: CJW
• UDI-Device Identifier: 00630414595825
• UDI-Public: (01)00630414595825(10)140205(17)250603
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222116
• 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): 02/10/2025

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: 06/03/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097530
• Device Lot Number: 140205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 06/06/2024
• 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