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

Model Number 10445107

Device Problem High Test Results (2457)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a discordant falsely elevated beta human chorionic gonadotropin (bhcg) patient sample result obtained on a dimension vista 1500 system.Siemens is investigating the event.

Event Description

A discordant falsely elevated beta human chorionic gonadotropin (bhcg) patient sample result was obtained on a dimension vista 1500 system.The discordant result was reported to the physician(s) who questioned the result.The same sample was then reprocessed on an alternate atellica im 1300 system, and a non-siemens system, and lower bhcg results, considered correct were obtained.Additionally, a qualitative kit testing was performed for the same patient sample, and a negative result was obtained.The lower reprocessed result from the non-siemens system was reported and the other reprocessed result was made known to the physician(s).No corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated beta human chorionic gonadotropin (bhcg) result.

Manufacturer Narrative

Additional information (03-mar-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc requested the customer send siemens the patient sample for internal investigation.Due to insufficient volume, no patient sample was provided.Hsc reviewed the instrument data and the information provided by the customer.Hsc concluded that the data provided is consistent with a heterophilic antibody indication in the instructions for use (ifu) for dimension vista beta human chorionic gonadotropin (bhcg) assay.The cause of the event was determined to be the potential presence of heterophilic antibodies or non-specific binding (nsb) interference.A potential product issue was not identified.The bhcg ifu states: "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 within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2022-00028 was filed on 04-feb-2022.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® BETA HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE(BHCG)
• 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: 13450927
• MDR Text Key: 287821804
• Report Number: 2517506-2022-00028
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063754
• 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
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: 10445107
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 21285BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2021
• 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
• Patient Sex: Female