MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® LOCI CA 15-3 FLEX® REAGENT CARTRIDGE (CA 15-3)

Model Number	10464344
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the event of a negative bias with the dimension vista loci ca 15-3 assay on the dimension vista system.Siemens has confirmed the dimension vista loci ca 15-3 assay showed a negative bias with patient samples.Siemens issued an urgent medical device correction, vc-22-02.A.Us dated (b)(6) 2022 and an urgent field safety notice vc-22-02.A.Ous dated (b)(6) 2022 to all dimension vista loci ca 15-3 customers.The letters instructed customers to use lot specific correlation factors provided for the affected lots.Siemens healthineers is working to restore assay performance and until such time, subsequent lots of dimension vista loci ca 15-3 may contain an alert card within the carton listing lot specific correlation factors.
Event or Problem Description
A customer reported that they noticed a shift in results when doing patient correlations testing for cancer antigen 15-3 (ca15-3) on the dimension vista® 500 system, serial number (b)(4).Patient correlation sample results were not reported to physicians.There are no known reports of patient intervention or adverse health consequences due to the reported event.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® LOCI CA 15-3 FLEX® REAGENT CARTRIDGE (CA 15-3)
• 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: 15165518
• Report Number: 2517506-2022-00203
• Device Sequence Number: 17306317
• Product Code: MOI
• UDI-Device Identifier: 00842768028526
• UDI-Public: 00842768028526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K100344
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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: 07/07/2022
• Device Model Number: 10464344
• Device Catalogue Number: K6456 SMN 10464344
• Device Lot Number: 21188BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-07/26/2022-003-C
• Patient Sequence Number: 1
• Patient Sex: Unknown