MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens customer care center to report an observation of discordant low atellica ch 930 urinary/cerebrospinal fluid protein (ucfp), lot 120243 results on a urine sample.The retest result on an alternate method was higher and reported as correct.The interpretation of results section of the 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 is investigating.
Event or Problem Description
The customer informed siemens of discordant low atellica ch 930 urinary/cerebrospinal fluid protein (ucfp), lot 120243 results on a urine sample.The retest result on an alternate method was higher.The discordant results were not reported.The sample was retested using an alternate ucfp method and the result was reported as correct and not questioned by the physician.Qc were all within the normal ranges.The patient has type 2 diabetes, medication is unknown.There are no allegations of patient or user intervention or adverse health consequences due to the issue.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2023-00164 on 2023-08-11.Additional information - 2023-08-15 siemens completed investigation for an outside of the united states (ous) customer observation of discordant low atellica ch 930 urinary/cerebrospinal fluid protein (ucfp), lot 120243 results.The initial issue was reported as inconsistent atellica ch urinary cerebrospinal fluid protein (ucfp) recovery in comparison to third-party reagent manufacturer's cerebrospinal and urine total protein.The customer observed atellica ch ucfp recovery below the measurement interval of 60 mg/l.The same sample was processed on a non-siemens analyzer configured to process third-party reagent manufacturer's cerebrospinal and urine total protein.The method recovered a value of 101 mg/l.Siemens has reviewed the available information and made the following determination.Atellica solution interface provides available test details which includes in-depth patient information.The test details screen provides the calculated concentration in comparing the sample signal against its valid atellica ch ucfp calibration curve.That calculated concentration is a negative number which concerns the customer.Samples which recover below the default measurement interval of 60 mg/l will suppress the result value and report a general <60 mg/l with the result flag 'measurement interval'.The signal response by the patient samples was below the limit of detection therefore supports little to no detection of protein within the patient sample.The limit of detection is set as the lowest concentration of protein that can be detected at a probability of 95%.Siemens investigation included an assessment of reagent, instrument, and sample data.Calibration curve met auto-acceptance and ucfp qc recovery was within range supporting that the reagent was working as intended.There was no indication from the atellica ch ucfp test that the recovery was inaccurate or did not meet the clinical picture.No issues were reported with other patient samples.No process errors were reported.No hardware intervention was completed.Based on the available information, the cause of inconsistent recovery between the methods may include method detection, clinical analyzer bias, and/or sample interferents.Siemens reports no claims of correlation between siemens healthineers ucfp and third-party reagent for detection of total protein.The atellica ch hardware and software is acting within expectation in consideration of sample result flagging and reporting of a negative concentration.A product performance issue has not been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17509507
• Report Number: 1219913-2023-00164
• Device Sequence Number: 17717869
• 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): 09/15/2023

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: 07/27/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown