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

Model Number	ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal complaint was opened to document the information for the atellica ch ecre_2.Separate complaints were opened and mdrs filed to address the siemens advia ecre_2 assay.This mdr is to document the information for the atellica ch ecre_2 assay only.It is also expected that the siemens dimension and dimension vista enzymatic assays would be impacted in a similar way to the siemens advia and atellica ch ecre_2 assays and a separate complaint was opened and mdrs filed to address those assays.The instructions for use (ifus) for the siemens advia, atellica ch, dimension and dimension vista enzymatic creatinine assays will be updated to reflect this information.An urgent medical device correction (umdc) achc20-01.A.Us.Chc was sent to advia chemistry us enzymatic creatinine customers and an urgent field safety notice (ufsn) achc20-01.A.Ous.Chc was sent to advia chemistry ous enzymatic creatinine customers in december 2019.An urgent medical device correction (umdc) achc20-01.A.Us.Dm was sent to dimension clinical chemistry us enzymatic creatinine customers and an urgent field safety notice (ufsn) achc20-01.A.Ous.Dm was sent to dimension clinical chemistry ous enzymatic creatinine customers in december 2019.An urgent medical device correction (umdc) achc20-01.A.Us.Dv was sent to dimension vista us enzymatic creatinine customers and an urgent field safety notice (ufsn) achc20-01.A.Ous.Dv was sent to dimension vista ous enzymatic creatinine customers in december 2019.The umdc and ufsn advise customers the "limitations of the procedure" section of the instructions for use (ifu) for the advia chemistry ecre_2 assay, dimension ezcr assay and the dimension vista ecrea assay will be updated to indicate that 'use of this assay is not recommended for patients undergoing treatment with phenindione, due to the potential for falsely depressed results'.An urgent medical device correction (umdc) achc20-01.A.Us was sent to atellica chemistry us enzymatic creatinine customers and an urgent field safety notice (ufsn) achc20-01.A.Ous was sent to atellica chemistry ous enzymatic creatinine customers in december 2019.The umdc and ufsn advise customers that the "limitations" section of the instructions for use (ifu) for the atellica ecre_2 assay will be updated to indicate that 'use of this assay is not recommended for patients undergoing treatment with phenindione, due to the potential for falsely depressed results'.
Event or Problem Description
Siemens healthcare diagnostics has become aware of the potential of falsely depressed creatinine results for patients undergoing phenindione therapy when using the enzymatic methodology.Advia ecre_2 results on a patients' samples showed interference with the phenindione drug and/or its metabolites.The atellica ch ecre_2 assay uses the same reagents, calibrators, and assay condition as advia ecre_2, and is expected to show a similar negative interference in samples from patients on phenindione therapy.Phenindione is not listed as an interfering substance in the atellica ch enzymatic creatinine_2 (ecre_2) instructions for use (ifu).

• Brand Name: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• Common Device Name: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9512754
• Report Number: 2432235-2019-00465
• Device Sequence Number: 16240335
• Product Code: JFY
• UDI-Device Identifier: 00630414595795
• UDI-Public: 00630414595795
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K070727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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 Model Number: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• Device Catalogue Number: 11097533
• Device Lot Number: ALL LOTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-12/19/2019-007-C
• Patient Sequence Number: 1