MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2); ENZYMATIC CREATININE_2 ASSAY

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	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer observed a falsely depressed enzymatic creatinine_2 (ecre_2) result on a female patient sample on an atellica ch 930 analyzer.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on alternate atellica ch 930 analyzers.The repeat results were higher than the discordant result.The repeat results were considered as the correct results by the physician(s).Calibration and quality controls (qc) were within the range for ecre_2.The interpretation of results section of the atellica ch ecre_2 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".Siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer observed a falsely depressed enzymatic creatinine_2 (ecre_2) result on a female patient sample on an atellica ch 930 analyzer.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on alternate atellica ch 930 analyzers.The repeat results were higher than the discordant result.The repeat results were considered as the correct results by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ecre_2 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00105 on apr 19, 2023.Additional information may 04, 2023: the customer observed a falsely depressed enzymatic creatinine_2 (ecre_2) result on a female patient sample on an atellica ch 930 analyzer, lot 120236.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on alternate atellica ch 930 analyzers.The repeat results were higher than the discordant result.The repeat results were considered as the correct results by the physician(s).Siemens was unable to query atellica cm00764 data for sample id (b)(6).The customer reported discordant (low) atellica ch ecre_2 result.Units: mg/dl.Subsequent repeat testing occurred on alternate instruments (cm00329 and cm00767).Errors associated with discordant result: unknown sample id: (b)(6).Initial result: 0.24 mg/dl.Alternate results: 0.84, 0.83 mg/dl.Siemens was unable to determine if indication of reagent delivery, or evidence of foaming issue occurred without photometer or result monitor data.(b)(6) 2023 - contacts for dilution arm cables and electric connectors were cleaned.(b)(6) 2023 - replaced reagent 1 (r1) probe, reset placement of cuvette segment, corrected routing of tubing to dilution and sample mixer washing stations.Process errors posted on 3/12, 3/14, 3/16, 3/22, 3/23, 3/24, 3/25.Dilution arm : dilution arm : bleach not detected, dilution arm : pressure transducer : sample abnormal aspiration, dilution arm : pressure transducer : sample clog detected, dilution arm : pressure transducer : sample not aspirated, dilution arm : arm : sample not detected, siemens provided troubleshooting recommendations to the customer if the issue reoccurs.The initial issue was reported as discordant (low) atellica enzymatic creatinine_2 (ecre_2) result.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as sample integrity, preanalytical variables cannot be ruled out.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Repeat of the same samples yielded expected results.Based on the results of the investigation, return of the patient sample is not warranted.A potential product issue has not been identified.Customer instrument is fully functional in section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• Common Device Name: ENZYMATIC CREATININE_2 ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): FUJIFILM WAKO PURE CHEMICAL CORPORATION; registration # 3003522182; 1-2, doshomachi 3-chome; chuo-ku, osaka 540-8 605; JA 540-8605
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16769960
• Report Number: 1219913-2023-00105
• Device Sequence Number: 3139252
• Product Code: JFY
• UDI-Device Identifier: 00630414595795
• UDI-Public: 00630414595795
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070727
• 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): 05/26/2023

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: 09/12/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097533
• Device Lot Number: 120236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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 Age: 38 YR
• Patient Sex: Female