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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center regarding a positive dimension sars-cov-2 total antibody (cov2t) patient sample result obtained on a dimension vista 1500 system.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).Siemens is investigating the event.
Event or Problem Description
The customer considered a positive dimension vista sars-cov-2 total antibody (cov2t) result on a patient sample processed on a dimension vista 1500 system to be discordant.The patient result was reported to the physician.The same patient sample was processed on a non-siemens instrument system using an immunglobulin g (igg) methodology.A negative result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant dimension vista cov2t patient result.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00116 was filed 14-may-2021.Additional information (19-may-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc has reviewed the instrument data.No product non-conformance was identified with the assay or the analyzer.The event involved a patient sample which reported a result of positive using the dimension vista sars-cov-2 total antibody (cov2t) assay.The customer repeated the same sample using a non-siemens sars-cov-2 igg antibody assay and the result was reported as negative.The calibration and quality control (qc) for the dimension vista cov2t assay were within acceptance limits at the time of the event and there were no process errors indicating both the assay and the instrument were operating within specifications.The dimension vista cov2t assay is a qualitative assay for detection of the presence of igg and igm antibodies to the sars-cov-2 s1 rbd protein.The non-siemens assay is a qualitative assay for detection of the presence of igg antibodies to the sars-cov-2 s1 rbd protein.The patient sample was not repeated on the dimension vista and the customer states there is no sample left for further testing.The patient had previously been infected with the sars-cov-2 virus 8 months prior, so the dimension vista assay result is consistent with patient history.Hsc cannot rule out that the positive cov2t result is not from a mixture of igm and igg antibodies while the concentration of only the igg antibodies was not high enough to trigger a positive result with the non-siemens sars-cov-2 igg assay.There is no claim of correlation between the dimension vista cov2t assay and the non-siemens sars-cov-2 igg assay.The discordance between the two assays may be tied to patient specific differences.The cause of the discrepancy is unknown.The device is performing within specifications.No further evaluation is required.Although there is no potential for serious injury in this case, an mdr was reported to the fda as a requirement of the emergency use authorization (eua).Section h6 has been updated to reflect the hsc investigation.

• 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: 11824527
• Report Number: 2517506-2021-00116
• Device Sequence Number: 4443440
• Product Code: QKO
• UDI-Device Identifier: 00630414605500
• UDI-Public: 00630414605500
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 09/10/2021
• Device Catalogue Number: K7414 SMN 11417414
• Device Lot Number: 20349BD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1