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 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

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 reported out to the physician(s), which was questioned.The customer tested a new sample on the same dimension vista instrument, resulting lower.The customer repeated the new sample on an alternate dimension vista instrument, resulting lower than the initial result.The customer issued a corrected report 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 2517506-2017-00237 was filed on march 08, 2017.Additional information (04/13/2017): the siemens headquarters support center (hsc) reviewed the data supplied.Hsc found no indication of reagent delivery issues.No further issues were reported, related to this issue.The cause of the discordant, falsely elevated creatinine result is unknown.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 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: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6389915
• MDR Text Key: 69442034
• Report Number: 2517506-2017-00237
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/27/2017

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: 02/13/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2011
• 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
• Patient Age: 45 YR