MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER,

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 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A ccc specialist reviewed the instrument data and found no reagent or instrument issues associated with this event.Quality control (qc) was within range on the day the event occurred.The ccc had performed diagnostic troubleshooting, which passed.The customer ran precision, resulting within specifications.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse cleaned the aliquot probe, reinstalled and aligned it.A siemens headquarters support center (hsc) specialist has reviewed the instrument data which indicated there was no issue related to a reagent non-conformance or instrument malfunction.Hsc has concluded that this issue is an isolated event specific to sample handling and or sample integrity.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low glucose (glu) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was reported to a nurse(s) who questioned it.The patient was redrawn and the test was repeated via a handheld device, resulting higher.The original sample was then repeated twice, on the same dimension vista instrument, resulting higher than the initial result and matching the patient's clinical picture.The first of the replicate results was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glu result.

• 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 #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6863308
• MDR Text Key: 86135189
• Report Number: 2517506-2017-00703
• Device Sequence Number: 0
• Product Code: CFR
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• 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: 08/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2017
• 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