MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).The customer's quality controls (qc) were within the acceptable ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the instrument and replaced the sample probe 1 (s1) mixer due to performance at the low end of acceptability on s1 mix service method.During the follow-up visit, the cse replaced the reagent 1 (r1) mixer board as it was failing.A siemens headquarters support center (hsc) specialist reviewed the instrument data and determined that there were no process or sample errors at the time when low result was obtained.The hsc specialist concluded that the issues with sample addition and mix could lead to low results.The issue was resolved by correcting the s1 and r1 mixing issues.The cause of the discordant, falsely low bhcg result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on the same dimension vista instrument and on an alternate dimension vista instrument, resulting higher.The corrected result from the alternate instrument was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low bhcg result.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7312710
• Report Number: 2517506-2018-00134
• Device Sequence Number: 11131810
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 03/05/2018

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 Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR