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 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The quality controls (qc) were within range on the day of the event.The ccc specialist reviewed the instrument data, which indicated a sample mix issue.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the sample probe 1 (s1) mixer.The cse aligned the arm and ran mix test, which passed.The cse ran an alignment test, which passed.The cse ran a quick check, which passed.The customer ran calibrations and qc, which passed.The cause of falsely depressed glu results on patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed glucose (glu) results were obtained on two patient samples on a dimension vista 1500 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the alternate dimension vista instruments, resulting higher.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 depressed glu results.

• 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 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6343968
• MDR Text Key: 67927324
• Report Number: 2517506-2017-00185
• Device Sequence Number: 0
• Product Code: CFR
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• 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: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2008
• 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