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 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer's quality control (qc) was out low of the acceptable limits for level 1 and level 2 when the event occurred.A siemens customer service engineer was dispatched to the customer's site.The cse installed clean repair kit and power flushed the integrated multi-sensor technology (imt) system.The cse ran dilution check several times and rebuilt imt rotary valve.The cse inspected the imt mixer.The cse replaced the imt pump tubing and aligned it.The cse performed another power flush with hot water, checked the rotary valve after which the leak test passed.The cse ran precision, resulting poor with the first result low.The cse then replaced the rotary valve, after which sodium (na) was running high.The cse replaced the imt module and ran qc, resulting within specification.The cse auto aligned the imt module.The cse primed the imt fluids, ran calibration and dilution check, resulting satisfactory.The cse ran qc, resulting within range.The cause of the discordant, na results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant sodium (na) results were obtained on patient samples on a dimension vista 1500 instrument.The initial results were reported to the physician(s).The samples were repeated on an alternate dimension vista instrument and the results matched the patients' previous results.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, na 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 CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 7026425
• MDR Text Key: 92875631
• Report Number: 2517506-2017-00818
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1