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

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant sodium results.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed proactive service.The cse replaced the aliquot probe and the reagent arm 1 (r1) probe and auto aligned them.The cse ran quick check without any error.During follow-up, service methods were run and results were acceptable.The cause of the discordant sodium results is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely high sodium results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s) for all patients except sample id (b)(6).The same samples were repeated on the same instrument, and recovered lower.The corrected results were reported to the physician(s).The customer stated that one (b)(6) patient was referred to the er and found to have normal electrolytes upon redraw.No other patients were affected.It is unknown which sample id and results are associated with this patient.There are no reports of patient intervention or adverse health consequences due to the discordant sodium results.

Manufacturer Narrative

The initial mdr was filed on aug 30, 2017.

Manufacturer Narrative

Additional information (10/23/2017): a siemens headquarter support center (hsc) specialist reviewed the information provided.Poor sample quality and the presence of gel, fibrin, and/or cellular material in sample(s) causing an obstruction, cannot be ruled out as a contributing factor.Frequency of e142: "integrated multisensor technology (imt) measurement error/e-verify" errors on patient samples around time of discrepant samples, may indicate that an air leak was present due to improperly seated fluids, or loose tubing connections, or other issue with the imt rotary valve.A product problem with the imt multisensor has not been identified.Hsc concluded that the probable cause of the discrepant results was an obstruction of fluid flow in the imt system and a sample specific issue due to poor sample quality, however, the cause could not be determined.The instrument is performing according to the specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6832023
• MDR Text Key: 84132287
• Report Number: 2517506-2017-00677
• 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,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• 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: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2012
• 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