MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® 500 SYSTEM

Model Number	DIMENSION VISTA® 500 SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported that a discordant, falsely depressed total bilirubin (tbil) result was obtained on the dimension vista 500 system s/n (b)(4).Siemens healthcare diagnostics headquarters support center (hsc) completed the investigation of the event.Hsc has reviewed the information provided and the instrument data.Instrument data for this event indicated multiple sample runs were processed for sample (b)(4) on dv330483.The customer investigation indicated, "they performed their own investigation and found that this patient had an add on test and the operator processed the add on test from a tube that had been diluted.Customer stated they do not believe this was an instrument issue but instead operator error".Hsc concludes the root cause of this event is due to operator error by processing the add on test from a tube that had been diluted.There is no evidence of an instrument or assay product nonconformance.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant depressed total bilirubin (tbil) result was obtained on a patient sample on a dimension vista 500 instrument.The result was reported to the physician(s) and questioned.The same sample was reprocessed on the same instrument and a higher result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed tbil result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® 500 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8517973
• Report Number: 2517506-2019-00148
• Device Sequence Number: 13821715
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 04/16/2019

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® 500 SYSTEM
• Device Catalogue Number: SMN10488217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR