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 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Quality control (qc) was within specification on the day the event occurred.The ccc specialist reviewed the instrument data which indicated that the integrated multi-sensor technology (imt) calibration was satisfactory but the peristaltic pump rate was low.The ccc specialist reviewed the process error log which showed imt probe pressure transducer error.A siemens customer service engineer (cse) was dispatched to the customer's site.After analyzing the instrument, the cse rebuilt the imt pump and found the imt metering pump full of air.The cse performed a total rebuild of the imt.The cse primed the system and ran quick check, resulting satisfactory.The cse reset the instrument and qc, which resulted within ranges.The cause of the discordant, falsely elevated na result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated sodium (na) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was not reported to the physician(s).The sample was auto repeated, resulting lower.The sample was then repeated on an alternate instrument, resulting the same as the auto repeated result.The alternate 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 na 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6863280
• MDR Text Key: 86263753
• Report Number: 2517506-2017-00692
• 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
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• 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: 08/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2009
• 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
• Patient Age: 25 YR