MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGANOSTICS 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 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc reviewed the instrument data which indicated that quality control (qc) was within range on the day the event occurred and was unable to identify the cause of the issue.The cause of the discordant, falsely low cre2 results is unknown.Siemens is investigating the issue.

Event Description

Discordant, falsely low urine creatinine (cre2) results were obtained on two patients' samples on a dimension vista 1500 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting the same.The samples were then repeated a second time on the same instrument, resulting higher.The samples were tested a third time on an alternate dimension vista instrument, resulting higher and confirming the second repeat results from the original instrument.The results from the alternate dimension vista instrument were confirmed correct and were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low cre2 results.

Manufacturer Narrative

The initial mdr 2517506-2017-00419 was filed on april 21, 2017.Additional information (05/24/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided and found no instrument or reagent issues associated with the event.Hsc investigated the issue and determined it to be sample related.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGANOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6511737
• MDR Text Key: 73399306
• Report Number: 2517506-2017-00419
• Device Sequence Number: 0
• Product Code: CGX
• 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,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• 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: 05/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2012
• 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