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

Catalog Number 10697306

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Customer reported that patients treatments were compromised due to analyser not being available for testing when required in the high dependency unit.Customer also reported discordant potassium(k+) result on the instrument.There was no report of injury due to this event.

Manufacturer Narrative

Based on the information provided via e-mail, customer indicated that they investigated the issue related to discordant potassium result occurred last year, they had no information about it, and there have been no reports of additional occurrences thereafter.Customer indicated that patients were not treated based on the discordant potassium(k+) results.Customer also indicated that instrument has been serviced many times over past four months.Customer stated that there was no specific patient or event identified due to instrument not being available at present.Customer indicated that instrument has been running well all week.

Manufacturer Narrative

The initial mdr 1217157-2014-00059 was filed with fda on may 01, 2014.Additional information: customer indicated that siemens field service engineer is making weekly calls to this account and since they replaced the main board on april 3rd, there have been no further issues.

• 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 industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3785012
• MDR Text Key: 4435374
• Report Number: 1217157-2014-00059
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1