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

Model Number	DIMENSION VISTA 1500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report that a falsely depressed sodium (na) test result was obtained from a dimension vista 1500 instrument.The customer stated that the affected instrument was showing a negative bias in sodium test results versus the alternate dimension vista 1500 instrument.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.Siemens is investigating the alleged negative bias.
Event or Problem Description
A falsely depressed sodium (na) test result was obtained from a dimension vista 1500 instrument.The initial result was reported to the physician(s).The same sample was repeated the next day on an alternate vista 1500 instrument.The repeat result was considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed sodium (na) test result.
Additional Manufacturer Narrative
The initial mdr 2517506-2020-00344 was filed on 23-nov-2020.Additional information (23-nov-2020): a siemens customer service engineer (cse) updated the instrument to software version 3.9.3, removed the integrated multi-sensor technology (imt) pump panel and replaced 4 valves and the panel o-ring.The cse replaced the peristaltic pump tubing and primed all the pumps.A failed dynamic fluid pressure test was resolved by replacing the reagent r2 probe.The cse also replaced the imt bulk fluids and installed a new v-lyte sensor.Post service activities, the cse ran a correlation study with results that were acceptable to the customer.Siemens headquarter support center (hsc) reviewed the available information and concluded that the service activities performed returned the instrument to a fully operational state.The cause of the falsely depressed sodium (na) test result and instrument to instrument bias in sodium test results is unknown.The instrument is operating within specifications.No additional evaluation of this device is needed.Section h10 adverse event problem codes were revised.

• Brand Name: DIMENSION VISTA 1500 INSTRUMENT
• 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: 10889959
• Report Number: 2517506-2020-00344
• Device Sequence Number: 3316215
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 11/02/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1