MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500

Catalog Number 10696857

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

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

Event Date 02/12/2015

Event Type  malfunction  

Event Description

Customer stated that instrument had d60 (communications error) on the below date.(b)(6) 2015: pid ((b)(6)) was sent lis through rapidcomm.(b)(6) 2015: pid ((b)(6) ) was not sent lis through rapidcomm.However (b)(6) 2015: pid ((b)(6) ) was automatically sent to lis without customer operation.There was no report of serious injury due to this event.

Manufacturer Narrative

Siemens had investigated the issue based on the information available at the time complaint received and determined to be not reportable to fda.Investigation ((b)(6) 2015): testing consists of viewing the files sent and identifying instances of samples identified as invalid_message and determining if they have the characteristics of the problem.These characteristics include presence of one or more of the following conditions: 1.Duplication of test results with one appearing out of the normal transmission sequence for the instrument.2.Test results missing one or more of the required fields - in most cases the test name (however, all required fields could be seen on instrument).Conclusion: both supporting communication logs for incident (b)(6) showed examples of both behaviors in samples sent at different times.This supports the proposed root cause of interaction between the software code when building the messages to be sent by the two channels.Further investigation on this issue revealed additional information.3.Potential for a record from one sample data set to be transmitted as a record on a different sample data set.However, this scenario has not been observed by customers and siemens has not been able to reproduce this scenario in-house and it is extremely unlikely to occur.Based on the additional information on this issue, siemens medical affairs determined this issue as a low health risk on june 15, 2015.Siemens performed retrospective review of all complaints associated with the issue to determine their medical device reporting eligibility.Siemens investigated the issue and has identified the root cause; mitigations will be implemented in new software version.There was no report of injury due to this event.

Manufacturer Narrative

The urgent field safety notice (33114 rev.A) has been issued to notify all affected siemens customers about this issue on july 28, 2015.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 4905927
• MDR Text Key: 6534978
• Report Number: 1217157-2015-00090
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10696857
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1217157-07-24-2015-003-C
• Patient Sequence Number: 1