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 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer's site.The cse reviewed the data provided.The cse found multiple aliquot clot detect errors and probe errors during aspiration of the check reagent.The cse found gel on the aliquot probe and the aptio vista buffer tube static discharge plate was dirty.The cse cleaned the static discharge plate and all spills.The cse replaced the aliquot probe and ran auto-alignment.The cse performed a quickcheck, resulting within specification and range.The cse performed quality control (qc), resulting within range.The customer performed a precision test, resulting within range.The cause of the discordant, falsely elevated total bilirubin results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated total bilirubin results were obtained on five patient samples on a dimension vista 1500 instrument.The initial results were reported out to the physician(s), which were questioned.The customer repeated the same sample on an alternate dimension vista instrument, resulting lower.The customer repeated the same sample on the original instrument, resulting lower.Sample id (b)(6) did not have enough sample left, and was not repeated on the original instrument.The customer issued corrected reports.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin 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 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: 6465260
• MDR Text Key: 72115863
• Report Number: 2517506-2017-00356
• Device Sequence Number: 0
• Product Code: MQM
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2015
• 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