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

Model Number DIMENSION VISTA 500

Device Problem Mechanical Problem (1384)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer reported seeing a shift in quality control (qc) data following the replacement of the integrated multi-sensor technology (imt) sensor.Per the ccc specialist instructions, the customer installed new (imt) sensor on the instrument and performed comparison between the two qc results, which were within ranges.The customer drained bleach and hot water through the imt sample vent port.The cse auto-aligned the imt, imt probe, primed all imt fluids and reset the instrument.The customer then ran qc which resulted biased high.A siemens customer service engineer was dispatched to the customer's site.After analyzing the instrument, the cse cleaned the rotary valve ports and styleted all manifold ports.The cse primed and aligned diagnostics.The cse ran a passing quick check and sodium urine qc level 3 which remained high.The cse replaced standard b and standard a salt solutions and imt reagent lot, after which qc resulted within specification.The following day ((b)(6) 2017), the cse noted that the lyte qc was on the high side of the range.The cse rebuilt the imt rotary valve and auto-aligned it.The cse ran leak test.The cse primed the system.The cse performed a total service visit.The cse ran imt calibration and dilution check, after which the new factor had decreased to 1.0099.The cse ran imt qc levels 1 and 3, resulting near the mean.The cse ran multi qualification qc for all levels.The cause of the discordant, falsely elevated na results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated sodium (na) results were obtained on patient samples on a dimension vista 500 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate dimension vista instrument, resulting lower and meeting laboratory expectations.The corrected 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.

• Brand Name: DIMENSION VISTA 500
• 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: 7033393
• MDR Text Key: 93088195
• Report Number: 2517506-2017-00816
• 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
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1