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

Catalog Number	K4086 SMN 10445128
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the customer care center about abnormal assay flags obtained with the individual patient sample and discordant elevated result obtained upon dilution of the sample.A siemens headquarters support center (hsc) representative evaluated the instrument data logs and the information provided.Hsc has reviewed the data and observed abnormal assay flags indicating the result monitor expected absorbance/kcount was not met for a specific cuvette.Per the dimension vista operator's guide, results flagged for abnormal assay cannot be reported.Result monitor b for vanc measures nonspecific binding, which checks for aggregation when particles and samples are present without antibody, and flags at factor of 1.5 above mean.Nonspecific binding may be caused by a specific specimen that causes nonspecific agglutination of the particle or instability of the particle reagent.Diluting the sample will also dilute the interferent causing nonspecific binding.Siemens has been informed that the patient has been found to have two paraproteins.Hsc concluded that an interfering substance in the patient samples caused nonspecific agglutination of the vanc particle reagent which resulted in falsely elevated results.The system flagged the samples appropriately and is working as intended.The customer stated that quality control recoveries were within laboratory acceptance ranges.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant falsely elevated vancomycin (vanc) result was obtained on a patient sample on the dimension vista 1500 instrument.The result was reported to the physician who questioned the result.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated vanc result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 6868161
• Report Number: 2517506-2017-00709
• Device Sequence Number: 873514
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: 00842768015533
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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: 01/16/2018
• Device Catalogue Number: K4086 SMN 10445128
• Device Lot Number: 17016BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR