MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® 1500 SYSTEM

Model Number	DIMENSION VISTA 1500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics customer care center (ccc) was contacted by the customer for the discordant, falsely depressed total bilirubin result.The ccc directed the customer to perform a precision study and the result was acceptable.The customer resolved the issue with repeat of the original sample.No service was requested for the event.No product non-conformance was identified with the instrument or reagent.Quality control values were within laboratory ranges.The cause of the event is unknown.The customer was satisfied that this isolated incident may have been caused by sample integrity.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely depressed total bilirubin (tbil) result was obtained on an infant patient sample on the dimension vista 1500 system.The discordant result was reported to the physician(s) who questioned the result.A new sample drawn from the same patient was processed on an alternate dimension vista and a higher result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed total bilirubin (tbil) result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® 1500 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8263955
• Report Number: 2517506-2019-00031
• Device Sequence Number: 1691506
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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 Model Number: DIMENSION VISTA 1500
• Device Catalogue Number: SMN 10459469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1