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 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer quarantined the reagent pack on which discordant results were obtained and installed a new reagent pack.The customer ran quality control, which was acceptable.A siemens headquarters support center (hsc) specialist reviewed the instrument data and did not verify an instrument or reagent issue.The hsc specialist identified the reagent sequence number and well set for all the barcodes that were affected.The customer repeated the affected samples.The customer did not obtain any additional discordant results for crea method.The cause of the discordant, falsely low crea result on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low creatinine (crea) results were obtained on multiple patient samples on a dimension vista 1500 instrument.The operator provided some examples for the discordant patient samples.Sample (b)(6) were repeated on the same instrument using a different reagent lot, resulting higher.The samples were also repeated on an alternate dimension vista instrument, resulting lower.The results were reported.It is unknown if the initial results for sample (b)(6) were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low crea results.

Manufacturer Narrative

The initial mdr 1226181-2016-00064 was filed on february 09, 2016.Corrected information (02/12/2016): corrected information was obtained regarding the results, which were reported to the physician(s).

Event Description

Discordant, falsely low creatinine (crea) results were obtained on multiple patient samples on a dimension vista 1500 instrument.The operator provided some examples for the discordant patient samples.Sample ids (b)(6) were repeated on the same instrument using a different reagent lot, resulting higher.The samples were also repeated on an alternate dimension vista instrument.The results were reported.It is unknown which results were reported for sample ids (b)(6).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low crea results.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5424488
• MDR Text Key: 37849394
• Report Number: 1226181-2016-00064
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 01/15/2016

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: 01/15/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2008
• 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