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

Model Number DIMENSION VISTA 1500 INTERNATIONAL

Device Problem Low Test Results (2458)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc customer service engineer (cse) was dispatched to the account.No hardware issues were identified.Siemens headquarters support center analysis of the instrument data indicate that the cause for the discordant low glucose csf results is unknown.Although two separate sample ids were stated to contain atypical low results, it was noted that both had originated from the same patient.In each instance the sample was repeated from a new aliquot well and recovered considerably higher and within the reference range.Additionally, all results were based on the same calibration curve and used the same reagent flex well suggesting that this issue was neither due to calibration bias nor a problem with the reagent material.The associated error logs for this event show multiple aliquot related errors for bad sample detect and clog detected.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant, low glucose (glu) results were obtained on one patient's spinal fluid (csf) samples on the dimension vista 1500 instrument.The discordant results were not reported to the physician.The samples were repeated and correct results were reported to the physician.There are no reports of patient intervention or adverse health consequences due to the discordant, low glucose csf results.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; registration number 1336181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6204996
• MDR Text Key: 63322346
• Report Number: 2517506-2016-00550
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DIMENSION VISTA 1500 INTERNATIONAL
• Device Catalogue Number: SMN 10444802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2008
• 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