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

Catalog Number	K1039 SMN 10445162
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed glucose result.The customer noted that the sample had a black discoloration.This was the only sample with this issue.The customer processed other samples without issue.Quality control (qc) was reprocessed after this patient sample and it was within laboratory ranges.Hsc concluded that this is not a reagent lot or assay issue.There is no evidence of a product nonconformance.There was no indication of foaming or reagent delivery issues based on the instrument data files.A siemens customer service engineer (cse) was dispatched to the customer account.Product maintenance was performed and no further discordant glucose results were observed.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely depressed glucose (glu) result was obtained on a patient sample on the dimension vista 500 system.The discordant result was not reported to the physician.The same sample was reprocessed the same day with an alternate, non-siemens methodology and a higher result was obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed glucose result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® GLUCOSE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8316925
• Report Number: 2517506-2019-00036
• Device Sequence Number: 66072
• Product Code: CFR
• UDI-Device Identifier: 00842768015663
• UDI-Public: 00842768015663
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/07/2019

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: 09/19/2019
• Device Catalogue Number: K1039 SMN 10445162
• Device Lot Number: 18262BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1