MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® TSH THYROID STIMULATING HORMONE FLEX® REAGENT CARTRIDGE

Catalog Number	K6412 SMN 10445104
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00477, 2517506-2019-00478, 2517506-2019-00479, 2517506-2019-00480 were filed for the same event.The customer contacted the siemens customer care center (ccc) and reported an elevated discordant thyroid stimulating hormone (tsh) patient result was obtained on a dimension vista 1500 instrument.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely elevated thyroid stimulating hormone (tsh) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s) and questioned.The customer treated the patient sample the same day to test for interference.There are no known reports of adverse health consequences due to the discordant elevated tsh result.
Additional Manufacturer Narrative
Mdr 2517506-2019-00481 was filed on 18-dec-2019.Mdrs 2517506-2019-00477, 2517506-2019-00478, 2517506-2019-00479 and 2517506-2019-00480 were also filed for the same event on (b)(6) 2019.Additional information (19-dec-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated thyroid stimulating hormone (tsh) result.Hsc evaluated the information provided and the instrument data files.There was no indication of instrument issues when the patient's samples were processed.The results of the heterophilic antibody blocking (hab) treatment on the patient sample indicated a difference in recovery indicative of a sample specific interferent.As stated in the instructions for use (ifu) for loci thyroid stimulating hormone (tsh) on the dimension vista; "patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed." the cause of the discordant tsh result is due to a sample specific interferent.The patient sample was not requested to be returned for evaluation because the customer was able to perform adequate testing to determine the cause.This event is singular in nature and is limited to a single patient sample.The instrument is operational.No product non-conformance identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® TSH THYROID STIMULATING HORMONE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 9492037
• Report Number: 2517506-2019-00481
• Device Sequence Number: 1385090
• Product Code: JLW
• UDI-Device Identifier: 00842768015731
• UDI-Public: 00842768015731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 06/10/2020
• Device Catalogue Number: K6412 SMN 10445104
• Device Lot Number: 19162AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1