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	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed urinary/cerebrospinal fluid protein (ucfp) results on two patient samples from an atellica ch 930 analyzer.The falsely depressed results were not reported to the physician(s).The patient samples were repeated on an alternate testing platform.The repeat results were higher than the falsely depressed results.The repeat results were reported as correct to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ucfp results.
Additional Manufacturer Narrative
An outside the united states customer obtained falsely depressed urinary/cerebrospinal fluid protein (ucfp) results on two patient samples from an atellica ch 930 analyzer.The falsely depressed results were not reported to the physician(s).The patient samples were repeated on an alternate testing platform.The repeat results were higher than the falsely depressed results.The repeat results were reported as correct to the physician(s).The interpretation of results section of the atellica ch ucfp instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00170 on jun 19, 2023.Additional information, jul 27, 2023: an outside the united states customer obtained falsely depressed urinary/cerebrospinal fluid protein (ucfp) results on two patient samples on atellica ch 930 analyzer.The falsely depressed results were not reported to the physician(s).The patient samples were repeated on an alternate testing platform.The repeat results were higher than the falsely depressed results.The repeat results were reported as correct to the physician(s).Siemens evaluated the customer's observations and notification information.The complaint reported two patient samples which recovered values <60 mg/l while the alternate testing platform recovered a reportable concentration.Siemens was not able to identify the specific samples due to insufficient information.No unique sample identifier was provided to focus the investigation.Siemens acknowledges the customer's concern of atellica ch urinary/cerebrospinal fluid protein (ucfp) detection in comparison to alternate testing platform total protein in urine (tpuc) reagent, which attempts to quantify a similar total protein in urine or csf samples.Siemens considered generalized reasonings which would explain potential differences in total protein recovery between the two methods.The poorer correlation at lower concentrations can be attributed to the significant sample to sample variation in the concentration and composition of proteins and the differences in analytical specificity between the various assays.The observed differences are less significant as the protein concentration increases.This coupled with unique differences between the application of siemens atellica ch ucfp commercial assay to alternate testing platform tpuc may support inconsistent sample recovery at lower concentration.Key findings include differences in calibrator type and calibrator levels.Siemens atellica ch ucfp is a multilevel calibrator calibration which spans the measurement range while the alternate testing platform is a single level calibrator with focus at the middle of the measurement range.Due to the limited information, siemens is unable to determine a probable cause for the discordant replicates between the siemens healthineers atellica ch ucfp recovery versus alternate testing platform tpuc recovery.Potential causes may include assay differences between the two reagents.No patient sample return is required as the report of discordant replicates was isolated to two patient samples.No additional method concerns were reported.The customer and system are operational.There is no evidence to support that there are any issues with the atellica ch hardware and the commercial urinary/cerebrospinal fluid protein (ucfp) reagent.In section h6, the investigation finding, and investigation conclusion codes were updated.

• 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 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive; newark DE 19714 6101
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17151331
• Report Number: 2432235-2023-00170
• Device Sequence Number: 5589900
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: 00630414279206
• 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): Unknown
• 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): 08/17/2023

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: 09/19/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 120243
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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