MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number	DIMENSION VISTA 1500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.A siemens specialist remotely reviewed the result monitor on the dimension vista 1500 instrument and determined that the sample mixer on sever 3 needed to be replaced.The calibrations for ca and co2 were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.After inspecting the instrument, the cse replaced and aligned the sample mixer.Then, the cse tested the sample mixer and determined that the sample mixer was functioning acceptably.The cause of the discordant, falsely low ca and co2 results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.The customer was unable to identify when each discordant result was obtained.The customer only indicated that the affected samples were processed between 8 pm on (b)(6) 2019 and 11 am on (b)(6) 2019.Therefore, two mdrs (mdr 2517506-2019-00282 and mdr 2517506-2019-00283) were filed for this issue.
Event or Problem Description
Discordant, falsely low calcium (ca) results were obtained on two (2) patient samples and discordant, falsely low carbon dioxide (co2) results were obtained on four (4) patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate dimension vista instrument and higher results were obtained on the patient samples.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ca and co2 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2517506-2019-00283 on 10-jul-2019.Additional information (26-jul-2019): siemens further investigated the issue.Based on the data provided by the customer, siemens determined that the malfunctioned sample mixer potentially contributed to the discordant, falsely low calcium and carbon dioxide results.The replacement of the sample mixer resolved the issue.Mdr 2517506-2019-00282_s1 was filed for the same event.

• Brand Name: DIMENSION VISTA 1500
• Common Device Name: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8777563
• Report Number: 2517506-2019-00283
• Device Sequence Number: 19358570
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Model Number: DIMENSION VISTA 1500
• Device Catalogue Number: 10459469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1