MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION; DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Catalog Number	RF621 SMN 10464525
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens headquarters support center (hsc) has reviewed the customer information provided and the instrument data.The customer diluted the patient sample with dimension cardiac troponin sample diluent and reprocessed the sample after the initial result of <0.017 ng/ml was obtained.Siemens does not recommend diluting troponin i samples below 35 ng/ml with the dimension cardiac troponin sample diluent.If a customer wants to verify a below assay range (<0.017 ng/ml) troponin i sample, the sample should be diluted with a sample with an elevated troponin value (>0.056 ng/ml) in a 50% recovery method that is described in the dimension instrument operator's guide.Diluting a troponin i sample with a another sample that is below the assay range can lead to a false elevated result due to magnification by the dilution factor of the normal signal that is seen with a below assay range troponin sample.The result of the diluted sample was 0.128 ng/ml when the system applied the dilution factor.The cause of the event was determined to be due to nonstandard use diluting troponin i samples below the assay range of 0.017 ng/ml with a diluent that is only approved for diluting troponin i samples above the assay range.No product non-conformance was identified.The device is performing according to specifications.No further evaluation of the device is necessary.
Event or Problem Description
Discordant falsely elevated cardiac troponin i (tni) results were obtained on a diluted reprocessed patient sample on a dimension exl 200 instrument.The customer performed a dilution on the patient sample after a below assay range was obtained for the initial result.The discordant result was reported to the physician(s) and questioned.The same diluted sample was reprocessed on the same day at a later time on the same instrument and a higher result was obtained.The same sample was reprocessed undiluted on the next day on the same instrument and a lower result was obtained.A corrected report was issued with the lower undiluted result.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated cardiac troponin i results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8832547
• Report Number: 2517506-2019-00296
• Device Sequence Number: 2196586
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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 Expiration Date: 10/10/2019
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EC9283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1