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

Device Problem Low Test Results (2458)

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

Event Date 06/10/2021

Event Type  malfunction  

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 Description

A customer reported that they noticed a shift low in results when doing patient correlations testing for cancer antigen 15-3 (ca15-3) on the dimension vista® 1500 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®
• Type of Device: 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: 15165540
• MDR Text Key: 304959164
• Report Number: 2517506-2022-00202
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00842768028526
• UDI-Public: 00842768028526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 10464344
• Device Catalogue Number: K6456 SMN 10464344
• Device Lot Number: 21034BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2517506-07/26/2022-003-C
• Patient Sequence Number: 1