MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP); BIURET (COLORIMETRIC), TOTAL PROTEIN

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	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a discordant depressed urinary/cerebrospinal fluid protein (ucfp) result was obtained on a patient sample on an atellica ch 930 instrument.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate atellica ch 930 instrument.The repeat result was the same as the discordant result.The patient sample was repeated on an alternate non-siemens method at an alternate site and the result was higher.The customer is not sure which result is correct and sent both results to the physician without issuing a corrected report.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed ucfp result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a discordant depressed urinary/cerebrospinal fluid protein (ucfp) result obtained on a patient sample on an atellica ch 930 instrument.The customer stated that the ucfp quality control was in range on both atellica ch analyzers.Siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Additional information (06-may-2024): the patient sample is not available for further testing or investigation by siemens.Based on the available information, the cause of the discordant result is sample specific.No medical device issue identified.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2024-00087 was filed on 02-may-2024.

• Brand Name: ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 19232474
• Report Number: 2432235-2024-00087
• Device Sequence Number: 6834317
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: 00630414279206
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 07/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 130273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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: 30 YR
• Patient Sex: Female