MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® EZCR ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE

Model Number	10471520
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 dimension enzymatic creatinine (ezcr) 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 etamsylate drug on the dimension enzymatic creatinine (ezcr) 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 ezcr and compared these results with 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 ezcr results.Etamsylate (dicynone) is not listed as an interfering substance in the dimension enzymatic creatinine (ezcr) instructions for use (ifu).
Additional Manufacturer Narrative
Initial mdr 2517506-2020-00292 was filed 30-sep-2020.Additional information (27-oct-2020) siemens investigation is complete.Siemens will be updating the instructions for use (ifu) for dimension enzymatic creatinine (ezcr) 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 of 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: DIMENSION
• Common Device Name: DIMENSION® EZCR ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 10609401
• Report Number: 2517506-2020-00292
• Device Sequence Number: 14064863
• Product Code: JFY
• UDI-Device Identifier: 00842768030512
• UDI-Public: 00842768030512
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K073055
• 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: 10471520
• Device Catalogue Number: DF270B SMN 10471520
• Device Lot Number: ALL LOTS
• 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