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 01/15/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc reviewed the instrument data and found no errors during the time the sample was run.Ccc performed special methods testing on the instrument and found that reagent probe 5 (r5) bottom of cuvette (boc) needed adjustment.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument, the cse cleaned the reagent tray cover over cuvette ring.The cse replaced r5 vertical and horizontal belts.The cse realigned sample probe 3 mixer (s3), r5 probes and verified boc position.The cse checked the mixer motion, ran quick check, service methods and quality controls, resulting satisfactory except for level 3.During follow-up visits, the cse ran precision on patient samples, quick check and qc, resulting within range except for level 3 qc.A reagent loader failure prevented loading of fresh qc.The cse replaced the s3 timing drive belts, and internal ultra violet lamp, realigned the probes and verified that boc were aligned.The cse ran quick check and service methods for s3 mixer.The cse ran qc, resulting within range.A siemens headquarter support center (hsc) specialist reviewed the instrument data and concluded that the cause of the discordant, falsely elevated mg result is attributed to a faulty s3 mixer and misalignment of the s3 probe which was resolved by the replacement of s3 mixer, alignment of the s3 probe and other service performed.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated magnesium (mg) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was flagged "above panic range" and was auto re-run, resulting lower.The sample was then repeated on an alternate dimension vista instrument, resulting lower and confirming the auto repeated result.The alternate dimension vista instrument result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated mg 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 #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6312635
• MDR Text Key: 66873968
• Report Number: 2517506-2017-00130
• 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: 02/08/2017

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: 01/15/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2013
• 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