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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics headquarters support center (hsc) to report a falsely depressed vancomycin (vanc) patient sample result.Hsc reviewed the information provided by the customer and the instrument data logs.The calibration was within conformance and quality control replicates recovered within the customer's established ranges.Repeat of the same patient sample yielded expected results.There were no issues noted with other patient samples indicating that the instrument and assay were performing acceptably.The customer did not report any further concerns with the vanc assay or any additional discordant vanc results.A potential product issue has not been identified.The cause of the event is unknown.The device is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant falsely depressed vancomycin (vanc) patient sample result was obtained on a dimension vista® 500 system.The discordant result was reported to the physician and questioned.The same sample was reprocessed twice on the original system.The higher reprocessed results matched the patient history.The higher reprocessed result, considered correct, was reported.There were no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed patient vanc result.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® 500 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6104
• MDR Report Key: 12692717
• Report Number: 2517506-2021-00287
• Device Sequence Number: 14512850
• Product Code: JJE
• UDI-Device Identifier: 00842768015533
• UDI-Public: 00842768015533
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/25/2021

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
• Device Catalogue Number: SMN 10284473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1