MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION; DIMENSION® CV2T SARS-COV-2 TOTAL ANTIBODY ASSAY

Catalog Number	RF812 SMN 11417412
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
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 (cv2t) patient sample result obtained on a dimension exl 200.Siemens healthcare diagnostics headquarters support center (hsc) concluded the evaluation of the event.Hsc has reviewed the instrument data.No product non-conformance was identified.The questioned positive cv2t patient sample result was sent to an alternate laboratory and resulted negative on the alternate methodology.The patient was reported to have had two doses of a covid-19 vaccine.The dimension cv2t assay uses the antigen s1 rbd (spike receptor binding domain) which is the same antigen used in the vaccine.The alternate methodology covid assay was reportedly using a nucleocapsid antigen which is not used in currently available vaccines.When a patient receives the vaccine and produces an immune response to the vaccine, that immune response will produce antibodies to the s1 rbd antigen but not to the nucleocapsid antigens.The dimension cv2t assay performed according to specification and produced a correct result with this patient sample.The dimension cv2t result is not discordant but reflects that the patient received a covid-19 vaccine.The limitations section of the dimension sars-cov-2 (cv2t) 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." 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 considered a positive dimension sars-cov-2 total antibody (cv2t) result on a patient sample on a dimension exl 200 system to be discordant.The patient result was not reported.The same patient sample was sent to an alternate laboratory and processed on a non-siemens methodology.A negative result was obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant dimension cv2t patient result.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® CV2T 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: 11824524
• Report Number: 2517506-2021-00115
• Device Sequence Number: 4443439
• Product Code: QKO
• UDI-Device Identifier: 00630414605418
• UDI-Public: 00630414605418
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EUA201460
• 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): 05/14/2021

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: RF812 SMN 11417412
• Device Lot Number: EA1253
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1