MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® LOCI CA 19-9 FLEX REAGENT CARTRIDGE

Model Number	10464358
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant, falsely elevated cancer antigen 19-9 (ca19-9) result on a patient sample obtained on a dimension vista 500 system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely elevated cancer antigen 19 (ca19-9) patient sample result was obtained on a dimension vista 500 system during validation of a new ca 19-9 lot.The result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant ca19-9 result.
Additional Manufacturer Narrative
Additional information (b)(6) 2022: siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the falsely elevated loci cancer antigen 19 (ca19-9) patient sample result.Hsc reviewed the instrument data logs and information provided by the customer.No product non-conformance was identified with the ca 19-9 assay or the dimension vista 500 system.A siemens internal investigation was performed with an available ca19-9 assay lot retained by the manufacturer.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial was filed (b)(6) 2021.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® LOCI CA 19-9 FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; 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: 12392361
• Report Number: 2517506-2021-00226
• Device Sequence Number: 4699289
• Product Code: NIG
• UDI-Device Identifier: 00842768028533
• UDI-Public: 00842768028533
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 04/01/2022
• Device Model Number: 10464358
• Device Catalogue Number: K6457 SMN 10464358
• Device Lot Number: 21091BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown