MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA; DIMENSION VISTA® (COV2T) SARS-COV-2 TOTAL ANTIBODY ASSAY

Catalog Number	K7414 SMN 11417414
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center concerning a negative dimension vista sars-cov-2 total antibody (cov2t) patient sample result obtained on a sample that resulted as reactive/positive with another siemens sars-cov-2 total antibody assay on an alternate siemens system.Siemens headquarters support center (hsc) concluded the evaluation of the event.The instrument data logs for the dimension vista systems (b)(4) have been reviewed.No product non-conformance was identified with the instruments.The cause of the event is unknown.The patient sample dimension vista results were near the positive cutoff indicating an antibody actively near the cutoff.The limitations section of the dimension vista sars-cov-2 (cov2t) flex reagent cartridge instructions for use states: "this assay should not be used to diagnose or exclude acute infection.Results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings." "patient specimens may be nonreactive if collected during the early (pre-seroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients" a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).
Event or Problem Description
The customer obtained a discordant nonreactive (negative) dimension vista sars-cov-2 total antibody (cov2t) result on a patient sample on a dimension vista 500 system.The result was reported to the physician.The same sample was reprocessed for confirmation of the cov2t result on a later date after the initial result was questioned by the physician.The same sample was reprocessed on the same dimension vista system and on a second dimension vista system.The result was negative on both systems.The same sample was then processed with an alternate siemens methodology on a siemens atellica system and a reactive (positive) result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant dimension vista cov2t result.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® (COV2T) SARS-COV-2 TOTAL ANTIBODY ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11573997
• Report Number: 2517506-2021-00076
• Device Sequence Number: 3156856
• Product Code: QKO
• UDI-Device Identifier: 00630414605500
• UDI-Public: 00630414605500
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EUA201459
• 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): 03/26/2021

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: 03/14/2021
• Device Catalogue Number: K7414 SMN 11417414
• Device Lot Number: 20169BA
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR