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

Catalog Number 10696857

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/27/2014

Event Type  malfunction  

Manufacturer Narrative

Customer sent attached data stream file which was reviewed by the siemens software team and it was determined that a duplication was occurring.Investigation report: the spreadsheet shows two samples sent by the instrument to (b)(4) , one is invalid and the other contains good information.The problem in the invalid specimen is that the one parameter, in both cases (b)(4) is duplicated in the invalid one.In these examples the values are in different places in the invalid message.Since software (b)(4), the (b)(4) has dual port lis transmission capability meaning the system can be connected to 2 data management systems such as (b)(4) and another data management system(dms).This allows the system to communicate simultaneously over the serial and ethernet ports and configure each port to send patient, calibration, or qc data.User can select which data is sent over which port and can specify which port serves as the primary interface.Typically a user would setup one port as the primary port which would interface with (b)(4) or a lis and send out all the necessary data.They would then use the other port to just send out results, not have it setup to any type of lis.In this complaint,the customer is using this dual transmission feature but because they setup both ports to send out the same type of information, the data is getting duplicated and one port is then occasionally sending an "invalid' results message.Based on the information available at the time complaint received, siemens determined this complaint not reportable to fda because there was no safety issue to the patient or operator.Further investigation on this issue revealed additional information.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, 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.

Event Description

Customer indicated that instrument sent invalid result message to rcomm (data management system).There was no report of serious 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: 4905775
• MDR Text Key: 22655174
• Report Number: 1217157-2015-00094
• 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: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• 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
• Date Manufacturer Received: 07/28/2015
• 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