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

Catalog Number 10444801

Device Problem High Test Results (2457)

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

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics concluded their investigation and is unable to determine the cause of the discordant elevated total prostate specific antigen (tpsa) result obtained on a patient sample on the dimension vista system as the data was unable to be obtained from the event date.No repeat testing was performed on the original sample.Quality control was within specification during testing.The siemens customer service engineer (cse) was dispatched to the site.The cse performed the following repairs; replaced aliquot probe after a failed alignment, performed aliquot probe auto-align, primed fluids, replaced body probe assembly, performed reagent shuttle 2 auto-align, replaced aliquot probe holder assay due to a damaged level sense connector.Cse also inspected the imt std a rotary valve hold rates and confirmed the rates to be stable and in normal range.After instrument repair, the instrument was fully functioning and there were no further issues.The cause for the falsely discordant elevated tpsa result is unknown.The device is performing within specifications.No further evaluation of the device is required.

Event Description

A discordant elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension vista system.The result was reported to the physician and was not questioned.No corrected report was issued.A new sample was drawn at a later date and a lower result was obtained.There are no reports of patient intervention or adverse health consequences due to the discordant elevated tpsa result.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® SYSTEM 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; registration number 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6963279
• MDR Text Key: 90655631
• Report Number: 2517506-2017-00782
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143720
• 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: 10/19/2017

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 Catalogue Number: 10444801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No
• 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