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

Model Number	10445104
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely depressed loci thyroid stimulating hormone (tsh) patient sample result was obtained on a dimension vista 1500 system which was later determined to be discordant when compared to the results from alternate methodologies on a later date.The discordant result was reported to the physician(s) and the result was questioned at a later date.On a later date, a new sample was drawn from the same patient and processed on an alternate siemens system, and non-siemens systems at alternate facilities and higher tsh results, considered correct, were obtained and reported.There are no known reports of adverse health consequences due to the discordant falsely depressed loci thyroid stimulating hormone (tsh) result or due to the potential changes in treatment.
Additional Manufacturer Narrative
An (b)(6) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a discordant falsely depressed loci thyroid stimulating hormone (tsh) patient sample result obtained on a dimension vista 1500 system.Mdrs 2517506-2022-00108, 2517506-2022-00109, 2517506-2022-00110, 2517506-2022-00112 and 2517506-2022-00113 are filed for the same event.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (08-jun-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control and calibration results were within the customer's expected ranges.No patient sample was provided to siemens for internal investigation.The instructions for use (ifu) for the dimension vista- loci thyroid stimulating hormone (tsh) assay 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.As with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." based on the data available, hsc concluded that no potential product issue was identified with the tsh assay.The event involves a patient specific issue.The cause of the event is unknown.The system is fully operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2022-00111 was filed on 29-apr-2022.Initial mdrs 2517506-2022-00108, 2517506-2022-00109, 2517506-2022-00110, 2517506-2022-00112 and 2517506-2022-00113 were filed for the same event on 29-apr-2022.Mdr supplements 2517506-2022-00108 supplement 1, 2517506-2022-00109 supplement 1, 2517506-2022-00110 supplement 1, 2517506-2022-00112 supplement 1 and 2517506-2022-00113 supplement 1 are filed for the same event.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® THYROID STIMULATING HORMONE 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: 14254011
• Report Number: 2517506-2022-00111
• Device Sequence Number: 14661011
• Product Code: JLW
• UDI-Device Identifier: 00842768015731
• UDI-Public: 00842768015731
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K140859
• 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): 06/23/2022

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: 06/04/2021
• Device Model Number: 10445104
• Device Catalogue Number: K6412 SMN 10445104
• Device Lot Number: 20156BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2020
• 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 Age: 76 YR
• Patient Sex: Male