MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA (BHCG) BETA HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE

Model Number 10445107

Device Problem High Test Results (2457)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of united states customer contacted the siemens healthcare diagnostics remote service center (rsc) regarding a falsely elevated beta human chorionic gonadotropin (bhcg) result obtained on a patient sample on a dimension vista 1500 system.Siemens is investigating the event.Mdrs 2517506-2022-00266, 2517506-2022-00267, 2517506-2022-00269, 2517506-2022-00270, 2517506-2022-00271, 2517506-2022-00272 and 2517506-2022-00273 were filed for the same event.

Event Description

A discordant falsely elevated beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 1500 system.The result was reported to the physician(s).New samples were processed on later dates on alternate non-siemens systems and lower, negative results were obtained, considered correct, and reported.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated bhcg result.

Manufacturer Narrative

Additional information (15-dec-2022): ): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and concluded the event was not due to any issue with the beta human chorionic gonadotropin (bhcg) assay.There is no evidence of a potential product issue.Hsc reviewed the patient bhcg testing history and noted the consistently elevated bhcg results over multiple sample draws for the patient.A heterophile blocking study performed by the customer verified the presence of a non-specific binding interferent such as a heterophile antibody.The cause of the event is isolated to a patient specific issue.As stated in the limitations of procedure section of the dimension vista bhcg flex reagent cartridge instructions for use (ifu): "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the device is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect siemens' investigation.Initial mdr 2517506-2022-00268 was filed on 07-oct-2022.Mdrs 2517506-2022-00266, 2517506-2022-00267, 2517506-2022-00269, 2517506-2022-00270, 2517506-2022-00271, 2517506-2022-00272 and 2517506-2022-00273 were filed for the same event.Mdr supplements 2517506-2022-00266 supplement 1, 2517506-2022-00267 supplement 1, 2517506-2022-00269 supplement 1, 2517506-2022-00270 supplement 1, 2517506-2022-00271 supplement 1, 2517506-2022-00272 supplement 1 and 2517506-2022-00273 supplement 1 were filed for the same event.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA (BHCG) BETA HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• 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: 15561587
• MDR Text Key: 304377594
• Report Number: 2517506-2022-00268
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 10445107
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 22024BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female