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 Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

From the data received, it appeared that the sodium and chloride sensors were functioning properly.The patient sample had higher recovery for sodium chloride and potassium on system 31408 when compared to the sample run on system 31508.Most likely the sample run on (b)(6) 2016 at 12:37 on system 31408 was pre-analytical; due to the presence of salt being introduced to the sample from the sample port/luer area ahead of the sample.There is no evidence that the sensors were malfunctioning since there was no sodium drifts on the day of the event and 1 chloride drift 5 hours before the sample in question was run.

Event Description

Customer reported discordant sodium and chloride results on the analyzer.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500
• 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 industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5854495
• MDR Text Key: 52432094
• Report Number: 1217157-2016-00083
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1