MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. DIMENSION VISTA; CARDIAC TROPONIN I (CTNI) FLEX® REAGENT CARTRIDGE, PRODUCT CODE: MMI

Model Number	10445098
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) concerning the error flag result for cardiac troponin on the dimension vista 500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the event.Hsc has reviewed the instrument data.The measurement error flag indicates that the sample is recovering a reaction signal less than the lowest calibrator (result is significantly less than zero).This could be the result of a patient having a naturally low background reaction in the absence of the analyte (troponin i) or it could indicate that the patient has an interferent suppressing the loci reaction.The dimension vista operator's guide provides guidance as to how to handle the measurement error flag.The customer did not follow these recommendations resulting in the 2.5-hour delay in results documented in the escalation.A thorough review of the instrument record indicates that the patient samples were recovering at the threshold of the error flag indicating that an interferent is not likely and the difference between the plasma and serum was due to the normal variation between calibration and analyzers.The result of <15 ng/l was consistent with the patient presentation and is considered the correct result by the customer.The cause of the delay was failure by the customer to follow the operator's guide in troubleshooting the measurement error flag.The customer and system are fully operational.No product non-conformance was identified with the assay or instrument.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A customer reported that there was a delay in patient treatment of approximately 2.5 hours due to the inability to obtain an unflagged result when processing a patient sample for cardiac troponin i (ctni) on a dimension vista 500 system.The initial plasma sample produced an error flag and was not reported.The customer collected new plasma and serum samples.The new plasma sample produced the same measurement error.The customer then processed the serum sample and obtained an unflagged result.The result was considered true for the patient and was reported.There are no known reports of patient intervention or adverse health consequences due to the delay in reporting a ctni result.

• Brand Name: DIMENSION VISTA
• Common Device Name: CARDIAC TROPONIN I (CTNI) FLEX® REAGENT CARTRIDGE, PRODUCT CODE: MMI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11357596
• Report Number: 2517506-2021-00059
• Device Sequence Number: 4117520
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/22/2021

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: 01/29/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1