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

Catalog Number RF812 SMN 11417412

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 11824524
• MDR Text Key: 251213480
• Report Number: 2517506-2021-00115
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 00630414605418
• UDI-Public: 00630414605418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: RF812 SMN 11417412
• Device Lot Number: EA1253
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1