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

Model Number	RF621
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported discordant elevated cardiac troponin i (tni) patient results were obtained on a dimension exl instrument.Siemens healthcare diagnostics headquarters support center (hsc) is investigating the event.
Event or Problem Description
Discordant elevated cardiac troponin i (tni) results were obtained on a patient's samples on a dimension exl instrument.The results were reported to the physician.A lower result was obtained on a whole blood sample from the patient on the same day on an alternate non-siemens system at the user facility.The patient was transferred to another facility and a new sample tested the same day at the alternate facility also resulted lower.There are no known reports of patient intervention or adverse health consequences due to the discordant tni results.
Additional Manufacturer Narrative
Mdr 2517506-2019-00386 was filed on 15-oct-2019.Additional information (18-oct-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated cardiac troponin i (tni) result.Three sample tubes from the patient were returned to siemens for internal testing.Testing of the samples confirmed the elevated result on the dimension exl system as well as on an alternate siemens instrument with alternate methodology.One patient sample was processed after a heterophile blocking tube treatment.The tni results remained elevated.The second and third patient samples were reprocessed after dilutions were made.The results of the diluted samples showed a linear relationship on both siemens methodologies.The dilution results were inconsistent with a heterophilic antibody interferent.Hsc has reviewed the internal testing data as well as the original instrument data.While the testing cannot rule out heterophilic antibody interference, the testing was inconsistent with heterophilic antibody interference.The testing cannot rule out an interference from an immune complex or a persistence of troponin from a chronic cardiac condition.Hsc concluded that the instrument and assay are performing within specifications.It cannot be determined if the issue is a patient specific interferent or if there is a persistence of troponin from an underlying clinical condition.The cause is unknown.No product non-conformance was identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• 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: 9194649
• Report Number: 2517506-2019-00386
• Device Sequence Number: 3935045
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 03/28/2020
• Device Model Number: RF621
• Device Catalogue Number: SMN 10464525
• Device Lot Number: EB0088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR