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

Model Number	10445098
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 500 system.Siemens headquarters support center (hsc) reviewed the instrument data.No product non-conformance was identified with the assay or instrument.Sample id 2102303748a was producing troponin (ctni) results flagged with a measurement error.The customer did not initially follow the dimension vista operator's guide instructions for handling the sample and diluted the sample 1:5 using the onboard sample diluent.When this is done onboard, the lowest reportable value of this type of dilution is <0.075 ng/ml.The customer reported the value of 0.075 ng/ml (0.08 ng/ml) to the physician before following the operator's guide instructions for troubleshooting the measurement error flag using dilution of a sample with a known value.Following the operator's guide instructions, the customer was able to determine that the patient had an interferent that was affecting the ctni assay.The cause of event is operator use error in not recognizing the instrument result was <0.075 ng/ml and by not following the operator's guide instructions for handling a measurement error flag prior to reporting an incorrect result.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely elevated cardiac troponin i (ctni) result was obtained on a patient sample on a dimension vista 500 system.The discrepant result was reported to the physician(s).The sample was repeated with dilutions on the same system and an alternate dimension vista.No corrected result was obtained or reported.The patient was released from the facility by the physician.There was no allegation of patient harm due to the discordant elevated ctni result.

• 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: 11340177
• Report Number: 2517506-2021-00058
• Device Sequence Number: 19501039
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K063756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 09/04/2021
• Device Model Number: 10445098
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: 20309BD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1