MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

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	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens healthcare diagnostics remote service center (rsc) regarding erroneously depressed urinary/cerebrospinal fluid protein (ucfp) results on a patient sample obtained on an advia chemistry xpt system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed urinary/cerebrospinal fluid protein (ucfp) result on a patient sample on an advia chemistry xpt system.The initial result was not reported to the physician(s).The sample was reprocessed on the original system and an error message was obtained.Another random urine sample from the same patient was tested on the original system and a lower result was obtained, which was considered erroneous.Then, the customer processed patient's urine dipstick protein assay on sysmex uc-3500 instrument, which recovered positive and considered correct.Later, the patient went to an alternate facility to test ucfp with other platform, however, the sample data was not provided to siemens.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed ucfp results.
Additional Manufacturer Narrative
Additional information (20-nov-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.Hsc reviewed the quality control (qc) data which showed qc was recovering within acceptable range.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument and found no hardware issues.No additional issues were reported by the customer.The cause of the event is unknown.The analyzer 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 2432235-2024-00242 was filed on 22-oct-2024.

• Brand Name: ADVIA CHEMISTRY
• Common Device Name: ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20503955
• Report Number: 2432235-2024-00242
• Device Sequence Number: 8400916
• Product Code: CEK
• UDI-Device Identifier: 00630414279176
• UDI-Public: (01)00630414279176(10)160(17)250228
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 11/22/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11319151
• Device Lot Number: 160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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 Age: 51 YR
• Patient Sex: Female