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

Model Number	10445098
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2021-00031, 2517506-2021-00032, 2517506-2021-00033, 2517506-2021-00034, 2517506-2021-00035, 2517506-2021-00036, 2517506-2021-00037, 2517506-2021-00038, and 2517506-2021-00039 were filed for the same event.The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated cardiac troponin i (ctni) patient result was obtained on a dimension vista 1500 system.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely elevated cardiac troponin i (ctni) result was obtained on a patient sample on a dimension vista 1500 system.The discrepant result was reported to the physician(s).The patient was examined with ultrasound and angiography on an undisclosed date during a period of hospitalization and nothing abnormal was found.The patient's arthritis medication was discontinued and he was treated for pericarditis / myocarditis.The ctni result was questioned at a later date when another sample from the patient resulted within the reference range for creatine kinase mb subunit testing.There was no allegation of patient harm due to the discordant elevated ctni result or the procedure or treatment change.
Additional Manufacturer Narrative
Mdrs 2517506-2021-00031 supplement 1, 2517506-2021-00032 supplement 1, 2517506-2021-00033 supplement 1, 2517506-2021-00034 supplement 1, 2517506-2021-00035 supplement 1, 2517506-2021-00036 supplement 1, 2517506-2021-00037 supplement 1, 2517506-2021-00038 supplement 1, and 2517506-2021-00039 supplement 1 were filed for the same event.Additional information (01-apr-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated cardiac troponin i (ctni) results on multiple dates for one specific patient.Hsc reviewed the information provided by the customer.Hsc communicated to the customer that there is a possibility that the patient in question possessed a heterophilic antibody.Hsc requested the customer send the patient sample to siemens for further investigation.Since the event reported occurred in 2018, no patient sample from the event was available for evaluation.The dimension vista cardiac troponin i (ctni) flex reagent cartridge instructions for use states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the customer has accepted the conclusion of the siemens investigation as a possible explanation for the cause of the event.No potential product problem with the assay or instrument has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr was filed 26-jan-2021.Mdrs 2517506-2021-00031, 2517506-2021-00032, 2517506-2021-00033, 2517506-2021-00034, 2517506-2021-00035, 2517506-2021-00036, 2517506-2021-00037, 2517506-2021-00038, and 2517506-2021-00039 were filed for the same event.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® CTNI CARDIAC 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: 11231069
• Report Number: 2517506-2021-00030
• Device Sequence Number: 3229258
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K063756
• 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): 04/15/2021

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 Model Number: 10445098
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR