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 01/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer accepted remote connection from the ccc.A review of the quality control (qc) data showed that it was in range at the time of the event.The ccc auto-aligned reagent arm 5 and sample probe 3.The ccc ran a sodium hydroxide clean on reagent 5.The ccc homed all modules and reset the instrument.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse ran a diagnostics for mixers and cleaned drains.The cse found sample probe 3 was not properly aligned.The cse realigned the probe.The cse ran alignments and the customer ran calibration, resulting in range.The cause of the discordant, falsely depressed magnesium result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed magnesium result was obtained on a patient sample on a dimension vista 1500 instrument.The initial result was not reported out to the physician(s).The customer repeated a new sample on an alternate dimension vista instrument, resulting higher.The repeat result was released to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed magnesium result.

• 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6294322
• MDR Text Key: 66319280
• Report Number: 2517506-2017-00120
• Device Sequence Number: 0
• Product Code: JGJ
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/07/2017
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2014
• 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