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

Model Number DIMENSION VISTA 1500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/12/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The customer's quality control (qc) was in at the time of the event.The customer performed a precision run, resulting within range.The ccc did not find any process errors at the time of the event.Siemens is investigating the event.

Event Description

A discordant, falsely elevated creatinine result was obtained on a patient sample on a dimension vista 1500 instrument.The initial result was not reported out to the physician(s) as it was flagged for delta check.The customer repeated the same sample on the same dimension vista instrument twice, resulting lower.The customer repeated the same sample on an alternate dimension vista instrument.The second repeat result was reported out to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated creatinine result.

Manufacturer Narrative

The initial mdr 2517506-2017-00365 was filed on april 07, 2017.Additional information (05/16/2017): a siemens headquarters support center (hsc) specialist reviewed the escalation data.The 2.43 mg/dl and 1.54 mg/dl results were both processed from the same aliquot well (0).The 0.687 result came from a new well (9).Hemolysis index when processed from aliquot well 0 resulted higher than the hemolysis index obtained on well 9.Interference from cellular debris cannot be ruled out.There was no indication of reagent delivery.The data is consistent with possible sample integrity issue, however, the cause of the discordant creatinine result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

• 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6474327
• MDR Text Key: 72270626
• Report Number: 2517506-2017-00365
• Device Sequence Number: 0
• Product Code: JFY
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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: 05/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2013
• 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