MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; HIGH SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	10471067
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2021-00080 and 2517506-2021-00081 were filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) and reported that a discordant, falsely elevated high-sensitivity troponin i (tnih) patient result was obtained on a dimension vista 500 instrument.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension vista 500 instrument.The discordant result was reported to the physician and was questioned.The customer processed the sample with an alternate methodology on a non-siemens instrument and a lower result was obtained.A corrected report was issued.The customer stated that the patient's hospitalization was prolonged due to the discordant tnih result.There are no known reports of adverse health consequences to the patient due to the discordant tnih result or the prolongation of hospitalization.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00079 was filed on 18-mar-2021.Mdr 2517506-2021-00080 and mdr 2517506-2021-00081 were filed for this same event.Additional information (24-may-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated high-sensitivity troponin i (tnih) result on a dimension vista 500 system.Hsc has reviewed the instrument data.No product non-conformance with the assay reagent or analyzer was identified.A single patient produced grossly elevated troponin results (>25000 ng/l) with the dimension vista high sensitivity troponin i (tnih) assay.The result was not consistent with the physicians clinical interpretation.The elevation was consistent across multiple samples collected at different times which is inconsistent with acute myocardial infarction.Siemens healthineers requested the patient sample for further testing and investigation.The sample was returned to siemens healthineers for investigation of a potential heterophilic antibody interference.The sample was evaluated in the siemens technical support laboratory (tsl) using three different troponin assays manufactured by siemens healthineers as well as pretreatment using a heterophile blocker and linear dilution of the sample.The troponin assays used were the dimension vista tnih assay, the dimension vista cardiac troponin i (ctni) assay and the dimension rxl cardiac troponin i assay (ctni) with the heterogeneous immunoassay module on the dimension rxl system.The dimension vista ctni and tnih had a similar grossly elevated recovery with no apparent effect from the heterophile blocking tube and showed a linear dilution pattern.This result is inconsistent with antibody interference and indicates the troponin assays are picking up a persistence of troponin in the patient sample.The dimension vista ctni and tnih assays use different source reagent antibodies.Most heterophilic antibodies do not interfere with different source reagent antibodies in a similar manner.While the dimension rxl ctni assay uses the same source antibodies as the dimension vista ctni assay, the methodology is different which also indicates the elevation is not from an interferent.The tnih qc and calibration were within limits during the testing of the patient sample at the customer site indicating the tnih reagent was performing to specifications as well as the analyzer.The investigation showed the patient sample has a persistent elevation of troponin and not a heterophilic interference causing the falsely elevated troponin result.The patient has been tested with 4 different troponin i assays and 1 troponin t assay.All troponin results are concordant with a gross elevation of troponin being present in the patient sample.The cause of the troponin elevation was determined not to be from an issue or interference with the troponin assays.A persistent troponin elevation from a patient specific clinical condition cannot be ruled out or confirmed with the data that is available.The cause of the discordant result is unknown.The device is performing within specifications.No further evaluation is required.Mdr 2517506-2021-00080 supplement 1 and mdr 2517506-2021-00081 supplement 1 were filed for the same event.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA
• Common Device Name: HIGH SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11520258
• Report Number: 2517506-2021-00079
• Device Sequence Number: 19752510
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 05/30/2021
• Device Model Number: 10471067
• Device Catalogue Number: K6427 SMN 10471067
• Device Lot Number: 20216BC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR