MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® CRE2 CREATININE FLEX® REAGENT CARTRIDGE

Catalog Number	K1033A SMN 10872082
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely depressed creatinine (cre2) results were obtained on the dimension vista 500 system.Siemens headquarters support center (hsc) has completed their evaluation of the incident and the information provided.No product nonconformance with the instrument or reagent was identified.The issue was resolved by replacing the cre2 flex reagent cartridge on the same instrument.The cause is unknown.The device is operating per specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely depressed creatinine (cre2) results were obtained on patient samples on the dimension vista 500 system.The results were reported to the physician(s).The same samples were repeated on the same instrument or on an alternate vista instrument and higher results were obtained.Corrected results were issued.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed creatinine (cre2) results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CRE2 CREATININE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7454979
• Report Number: 2517506-2018-00276
• Device Sequence Number: 1373607
• Product Code: CGX
• UDI-Device Identifier: 00630414595016
• UDI-Public: 00630414595016
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 10/26/2018
• Device Catalogue Number: K1033A SMN 10872082
• Device Lot Number: 17299BA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1