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	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00218 was also filed for the same customer inquiry.The customer contacted siemens customer care center (ccc) and reported that discordant, falsely depressed tsh results were obtained on the dimension vista system.Siemens is investigating the incident.
Event or Problem Description
Discordant, falsely depressed thyroid stimulating hormone (tsh) results were obtained on patient samples on the dimension vista 1500 system.The results were not reported to the physician(s).After the next qc run was outside of approved range, the same samples were run on an alternate dimension vista system, resulting higher.The repeat results were reported.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed tsh results.
Additional Manufacturer Narrative
Original mdr (b)(6) 2018, additional information (30-apr-2018): siemens headquarters support center (hsc) has reviewed the instrument data and completed their evaluation.The event was limited to the samples processed from a single tsh flex reagent cartridge.The discordant low tsh results occurred after a flex switch from flex sequence number 4623 to sequence number 4627.Once the customer switched to a different sequence number flex, the qc and patient results returned to their relative expected values.No product nonconformance with the instrument or reagent was identified.The cause is unknown.Section h6 has been updated to reflect the hsc conclusion.No further evaluation of the device is required.

• 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: 7383371
• Report Number: 2517506-2018-00217
• Device Sequence Number: 10806246
• Product Code: JLW
• UDI-Device Identifier: 00842768015731
• UDI-Public: 00842768015731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 05/30/2018
• Device Catalogue Number: K6412 SMN 10445104
• Device Lot Number: 17150AA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1