MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGANOSTICS 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 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that quality control (qc) was running out of range low for level 1 and 3 after the discordant results were obtained.Ccc performed service method testing (smt) and found that sample arm 3 (s3) and the integrated multi-sensor technology (imt) mixers failed as well as the s3 alignment.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument, the cse replaced the s3 mixer and belts.The cse repeated smt for s3 mixer, resulting within range.The cse ran qc, resulting within range.The cause of the discordant, falsely low mg results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low magnesium (mg) results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results of patient samples (b)(6) and (b)(6) were reported to the physician(s).Patient (b)(6) was administered 2 doses of mg based on the erroneous result.The samples were repeated on the same instrument, resulting higher.Corrected reports were reported for patients id (b)(6) and (b)(6).The repeated results for all remaining patients were reported to the physician(s).There are no reports of adverse health consequences due to the discordant, falsely low mg results.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGANOSTICS 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6195256
• MDR Text Key: 63090307
• Report Number: 2517506-2016-00529
• 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: 12/21/2016

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: 12/02/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2012
• 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