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

Catalog Number 10492730

Device Problem Computer Software Problem (1112)

Patient Problem Not Applicable (3189)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is issuing urgent field safety notices (poc 17-008.A.Us and poc 17-008.A.Ous) to inform customers of the issue and provide them instructions on how to prevent it from occurring.This issue is due to a defect in the rapidpoint 500 v2.4 software.

Event Description

Siemens internal personnel identified an issue with rapidpoint 500 software version v2.4.There is a potential to misassign patient demographic information (last name, first name, gender, or date of birth) when the patient id field is left "blank" on multiple patient samples and a recall of the patient information is initiated.For example: · patient sample #1 is run with a blank patient id field and demographics are assigned (last name, first name, gender, or dob).· patient sample #2 is run with blank patient id field and different demographics are assigned (last name, first name, gender, or dob).· an attempt is made to recall patient sample #1 results but sample #2 demographics are displayed, not sample #1 demographics (results are for patient sample #1).This issue was identified internal to siemens.There have not been any external complaints for this issue.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• 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: 6472449
• MDR Text Key: 72558379
• Report Number: 3002637618-2017-00062
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10492730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• 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: Reuse
• Removal/Correction Number: Z-2040-2017
• Patient Sequence Number: 1