MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265; RL 1265

Catalog Number 10321852

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens reviewed instrument log files data.Customer had the patient list enabled on the analyzer.Customer ran patient a ((b)(6)).Customer ran patient b.During data entry, the customer accidentally selected "last patient" button which filled in the form with patient id (a), lastname (a's), firstname (a's), gender (a's), date-of-birth (a's), location (a's), physician (a's) and operator id (a's).Eventually customer recognized that data entry form was filled with data from patient a but that was patient b.However, instrument has a "clear all" button so if the data wasn't correct due to accidentally pressing "last patient", customer should have blanked the form at that point.The "last sample" option was created to accommodate a specific need in surgical suites where the system is measuring many back-to-back samples for the same patient during a procedure and the operator needed to minimize the amount of time spent doing data entry so that they could instead concentrate on the patient.The name chosen for this option in setup; secured options; analysis options is "save demographics".Unless customer is working in an or and running multiple back-to-back samples customer should be encouraged to turn off "save demographics".Customer has been advised to disable patient list feature.Analyzer is performing as intended.

Event Description

Customer reported that a sample with mixed up patient data has been send over rapidcomm (data management system) to lis (conworx poccelerator).There was no report of injury due to this event.

• Brand Name: RAPIDLAB 1265
• Type of Device: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5775809
• MDR Text Key: 49782125
• Report Number: 1217157-2016-00071
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10321852
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1