MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA® 1500 SYSTEM; DIMENSION VISTA 1500

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site.The cse analyzed the instrument and replaced the s1 belt, the s2 belt, probes and a vertical motor.Verification of tbil recovery by running 400 complete metabolic panels (cmp) with repeats on any tbil over 0.8 from the aliquot plate.All results are well within manufactures specification.The instrument is performing according to specifications.The cause of the discordant tbil results is unknown.No further action required.No further evaluation of this device is required.

Event Description

The customer stated that at least 70 discrepant, falsely elevated total bilirubin (tbil) results were obtained on a dimension vista 1500 instrument.The initial results were reported to the physician.The physician did not question the results.The tests were repeated on an alternate dimension vista 1500 and the results were lower.The repeated results were reported to the physician.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 SYSTEM
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration #: 1226181; 101 silvermine road; brookfield 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6494183
• MDR Text Key: 72886483
• Report Number: 2517506-2017-00371
• 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: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• 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: 03/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1