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

Model Number	10445128
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated and falsely depressed vancomycin (vanc) results.Hsc has reviewed the information provided by the customer and the system data.Calibration and quality control recovery was within conformance.No issues were noted with other patient samples indicating that the instrument and assays were performing acceptably.The customer and instrument are fully operational.A potential product issue has not been identified.The cause of the event in is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant, falsely elevated, and falsely depressed vancomycin (vanc) results were obtained on a patient sample on a dimension vista 500 system.The discordant results were not reported to the physician(s), and were questioned by the customer.The same sample was reprocessed multiple times the same day with the same instrument, and lower and higher results were obtained.One result was reported and considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated, and depressed vanc results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION VISTA®
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 10652548
• Report Number: 2517506-2020-00312
• Device Sequence Number: 2561879
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: 00842768015533
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• 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): 10/08/2020

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: 06/02/2021
• Device Model Number: 10445128
• Device Catalogue Number: K4086 SMN 10445128
• Device Lot Number: 20154BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1