MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA®; DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE

Catalog Number K1023 SMN10445160

Device Problem Low Test Results (2458)

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

Event Date 10/23/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument data indicate that the cause for the falsely depressed qc and patient results is unknown.The low ca results were obtained within a flex reagent cartridge well set.The low results were obtained from a single well set 12:6.The incident is under investigation by the siemens headquarters support center (hsc).

Event Description

Falsely depressed calcium (ca) results were obtained on qc and patient samples on the dimension vista 500 system.Patient results were reported.The same samples were rerun on the same instrument with an alternate reagent well set and higher results were obtained for the qc and patient samples.Corrected patient results were reported.There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed ca results.There was no report of adverse health consequences as a result of the falsely depressed ca results.

Manufacturer Narrative

Original mdr 2517506-2016-00412 was filed 22-nov-2016.The complaint was unable to be confirmed.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• MDR Report Key: 6120349
• MDR Text Key: 60653151
• Report Number: 2517506-2016-00412
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2017
• Device Catalogue Number: K1023 SMN10445160
• Device Lot Number: 16174BA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1