MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER,

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc instructed the customer to run quality control (qc) on both instruments, the results were satisfactory.The ccc specialist instructed the customer to run patient' correlation, resulting satisfactory.The customer stated that she had replaced the sample probe cleaner and the system diluent on the day the event occurred.Ccc instructed the customer to run precision with a known sample, validating results accuracy, for both within cups and between cups, this resulted accurate.The customer examined the peristaltic pump tubing and integrated multi-sensor technology (imt) tubing and cleaned the imt probe.The customer ran bleach and hot water through the sample vent ports, primed all imt fluids, aligned imt probe and module, which passed.The customer ran check 1 on imt probe and home all modules and reset the instrument.The customer replaced the v lyte multi-sensor and ran qc on levels 2 and 3, resulting within range.However, level 1 qc generated measurement errors, after which the customer repeated qc from fresh material in cups, and resulted within ranges.A siemens customer service engineer was dispatched at the customer site.After analyzing the instrument, the cse performed a power flush on imt module and aligned it.The cse found that the connection to the ppd pump was leaking, and tightened the fitting.The cse primed the ppd pump.The cse performed a quick check and ran precision, all resulted within specifications.The cse ran qc on lytes, resulting within range.The cse returned to the customer site for a follow up visit.The cse found the metering pump leaking due to improper mounting, and replaced it.The cse proactively replaced all valves on the imt pump module.The cse primed system fluids and ran quick check; all parameters resulted within range and within the acceptable standard deviation limits.The cse ran all levels of qc, resulting within range.The cause of the discordant, falsely elevated na results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated sodium (na) results were obtained on two patient samples on a dimension vista 1500 instrument.The discordant results were not reported to the physician(s).The samples were repeated on an alternate dimension vista instrument, resulting lower.The repeated results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated na results.

Manufacturer Narrative

The initial mdr was filed on august 2, 2017.Additional information (09/18/2017): a siemens headquarters support center (hsc) specialist reviewed the event data and service report and concluded that a maintenance need was responsible for the discrepant patient results.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield NY 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 6761672
• MDR Text Key: 81712923
• Report Number: 2517506-2017-00601
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1