MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number DIMENSION VISTA® 1500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer called a siemens technical support technician (tst) to report the discordant human chorionic gonadotropin (hcg) result.The tst recommended to repeat testing on the original sample.The customer stated that the discordant results was obtained with a special dilution, performed by a new operator.The quality controls (qc) was in range on the day of event.The cause of the discordant hcg result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s), who questioned it.A different sample, obtained from the patient on the same draw, was tested on the same instrument, resulting higher and matching patient history.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant hcg result.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6591178
• MDR Text Key: 75974909
• Report Number: 2517506-2017-00505
• Device Sequence Number: 0
• Product Code: DHA
• 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: 05/25/2017

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: 05/05/2017
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2011
• 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