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

Model Number	ENZYMATIC CREATININE_2 (ECRE_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens investigated the impact of etamsylate (also known as ethamsylate or dicynone®), which is reported to be an interferent in enzymatic creatinine assays.Based on the testing, etamsylate interferes with the atellica ch enzymatic creatinine_2 (ecre_2) assay, causing a >10% negative bias, at concentrations less than or equal to 6 mg/dl.Etamsylate is a sulfonic acid drug used as an antihemorrhagic agent.Etamsylate is a hemostatic drug only used outside of the united states.In some countries, it is approved only for veterinary use.Etamsylate is currently not available for use in the united states.
Event or Problem Description
Siemens investigated the impact of the drug etamsylate on the atellica ch enzymatic creatinine 2 (ecre 2) assay.Siemens processed samples at varying concentrations (1.50 mg/dl, 3.00 mg/dl, 4.50 mg/dl, and 6.00 mg/dl) of etamsylate for ecre 2 and compared these results with the results obtained a sample with no etamsylate.Siemens observed that the bias was greatest for the sample with the etamsylate concentration of 6.00 mg/dl.There are no known reports of patient intervention or adverse health consequences due to the negative bias observed in ecre 2 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2020-00392 on 30-sep-2020.Additional information (27-oct-2020): siemens investigation is complete.Siemens will be updating the instructions for use (ifu) for the atellica ch enzymatic creatinine_2 assay to include etamsylate as an interferent.Customers in countries outside the us (where the drug etamsylate may be prescribed) were notified of the interference issue and siemens plan to update the ifu.Etamsylate is a hemostatic drug only used outside of the united states.In some countries, it is approved only for veterinary use.Etamsylate is currently not available for use in the united states.

• 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: 10606551
• Report Number: 2432235-2020-00392
• Device Sequence Number: 13773564
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: Other
• Device Model Number: ENZYMATIC CREATININE_2 (ECRE_2)
• Device Catalogue Number: 11097533
• Device Lot Number: ALL LOTS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1