MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE

Catalog Number	K4086 SMN 10445128
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant vancomycin (vanc) results.Vanc assay calibration at the time the event was reported was within conformance.Vanc quality control (qc) samples successfully recovered within the customer established qc reference ranges before and after the observed flagged vanc results.Per the dimension vista operator's guide, the customer should not report results which prompt an abnormal assay flag.The customer should adhere to troubleshooting directions listed within the operator's guide which includes reprocessing the sample and processing quality control material to verify assay accuracy.After reporting of the issue to siemens healthcare diagnostics, the customer care center (ccc) discussed the appropriate action plan if a customer observes an abnormal assay result flag.Based on the evidence provided, hsc has attributed the reporting of the discordant vanc results to user error.There is no product non-conformance.The event was isolated to a singular patient.The dimension vista instrument operated as intended and the dimension vista instrument is fully operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant vancomycin (vanc) results were obtained on a patient sample on the dimension vista 500 system.An abnormal assay flagged result was reported to the physician(s).The same sample was repeated on an alternate vista instrument and abnormal assay flagged results were also obtained.There are no reports of patient intervention or adverse health consequences due to the discordant vanc results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8358257
• Report Number: 2517506-2019-00081
• Device Sequence Number: 10814476
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: 00842768015533
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• 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): 02/21/2019

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 Expiration Date: 09/26/2019
• Device Catalogue Number: K4086 SMN 10445128
• Device Lot Number: 18269BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1